FCS Magazine Spring 2022

SPRING 2022

Leader in Transition

Dr. Lucio Gordan assumes new, ‘data-driven’ role

Spring 2022

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For adults with polycythemia vera (PV) PV) who have had an inadequate response to or are intolerant of hydroxyurea ((HU) PV

EVERY DAY COUNTS. JAKAFI CAN HELP. PV is a hematologic malignancy that can become advanced in a subset of patients1-6 In a subset of patients, these characteristics may indicate advanced PV despite treatment with HU at the maximum tolerated dose and phlebotomy.1,7-10 Hct ≥45%

WBC count >11 × 109/L

or

Disease-related SYMPTOMS

In the phase 3 RESPONSE* trial, Jakafi demonstrated superior results† vs BAT‡ Composite Primary Endpoint

23%

(25/110) of patients receiving Jakafi achieved Hct control and ≥35% spleen volume reduction at week 32 vs <1% (1/112) of patients receiving BAT (P < 0.0001)11§

BAT, best available therapy; Hct, hematocrit; MPN-SAF, Myeloproliferative Neoplasm Symptom Assessment Form; TSS, Total Symptom Score; WBC, white blood cell.

*The RESPONSE (Randomized study of Efficacy and Safety in POlycythemia vera with JAK iNhibitor ruxolitinib verSus bEst available care) trial was a randomized, open-label, active-controlled phase 3 trial comparing Jakafi with BAT in 222 patients with PV. Patients enrolled in the study had been diagnosed with PV for at least 24 weeks, had an inadequate response to or were intolerant of HU, required phlebotomy for Hct control, and exhibited splenomegaly. All patients were required to demonstrate Hct control between 40% and 45% prior to randomization. After week 32, patients were able to cross over to Jakafi treatment.11,12 † The composite primary endpoint was defined as Hct control without phlebotomy eligibility and a ≥35% spleen volume reduction as measured by CT or MRI. To achieve the Hct control endpoint, patients could not become eligible for phlebotomy between weeks 8 and 32. Phlebotomy eligibility was defined as Hct >45% that is ≥3 percentage points higher than baseline or Hct >48% (lower value).11,12 ‡ BAT included HU (60%), interferon/pegylated interferon (12%), anagrelide (7%), pipobroman (2%), lenalidomide/thalidomide (5%), and observation (15%).11 § Jakafi 95% CI, 0.15-0.32; BAT 95% CI, 0.00-0.05.11

Indications and Usage Jakafi is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.

Important Safety Information • Treatment with Jakafi® (ruxolitinib) can cause thrombocytopenia, anemia and neutropenia, which are each dose-related effects. Perform a pre-treatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated • Manage thrombocytopenia by reducing the dose or temporarily interrupting Jakafi. Platelet transfusions may be necessary • Patients developing anemia may require blood transfusions and/or dose modifications of Jakafi • Severe neutropenia (ANC <0.5 × 109/L) was generally reversible by withholding Jakafi until recovery • Serious bacterial, mycobacterial, fungal and viral infections have occurred. Delay starting Jakafi until active serious infections have resolved. Observe patients receiving Jakafi for signs and symptoms of infection and manage promptly. Use active surveillance and prophylactic antibiotics according to clinical guidelines • Tuberculosis (TB) infection has been reported. Observe patients taking Jakafi for signs and symptoms of active TB and manage promptly. Prior to initiating Jakafi, evaluate patients for TB risk factors and test those at higher risk for latent infection. Consult a physician with expertise in the treatment of TB before starting Jakafi in patients with evidence of active or latent TB. Continuation of Jakafi during treatment of active TB should be based on the overall risk-benefit determination

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FCS Magazine

• Progressive multifocal leukoencephalopathy (PML) has occurred with Jakafi treatment. If PML is suspected, stop Jakafi and evaluate • Advise patients about early signs and symptoms of herpes zoster and to seek early treatment • Increases in hepatitis B viral load with or without associated elevations in alanine aminotransferase and aspartate aminotransferase have been reported in patients with chronic hepatitis B virus (HBV) infections. Monitor and treat patients with chronic HBV infection according to clinical guidelines • When discontinuing Jakafi, myeloproliferative neoplasm-related symptoms may return within one week. After discontinuation, some patients with myelofibrosis have experienced fever, respiratory distress, hypotension, DIC, or multi-organ failure. If any of these occur after discontinuation or while tapering Jakafi, evaluate and treat any intercurrent illness and consider restarting or increasing the dose of Jakafi. Instruct patients not to interrupt or discontinue Jakafi without consulting their physician. When discontinuing or interrupting Jakafi for reasons other than thrombocytopenia or neutropenia, consider gradual tapering rather than abrupt discontinuation • Non-melanoma skin cancers (NMSC) including basal cell, squamous cell, and Merkel cell carcinoma have occurred. Perform periodic skin examinations • Treatment with Jakafi has been associated with increases in total cholesterol, low-density lipoprotein cholesterol, and triglycerides. Assess lipid parameters 8-12 weeks after initiating Jakafi. Monitor and treat according to clinical guidelines for the management of hyperlipidemia • Another JAK-inhibitor has increased the risk of major adverse cardiovascular events (MACE), including cardiovascular death, myocardial infarction, and stroke (compared to those treated with tumor TNF

INTERVENE WITH JAKAFI IN YOUR PATIENTS WITH ADVANCED PV Individual Component of the Primary Endpoint

60 73% %

(66/110) of patients receiving Jakafi achieved Hct control at week 32 vs 19% (21/112) of patients receiving BAT11 To achieve the Hct control endpoint, patients could not become eligible for phlebotomy between weeks 8 and 32. Phlebotomy eligibility was defined as Hct >45% that is ≥3 percentage points higher than baseline or Hct >48% (lower value)11,12

Probability of Maintaining Hct Controla at 5 Years in RESPONSE Trial13,14 a

Absence of phlebotomy eligibility

Kaplan-Meier Estimate: Durability of Hct Control at 5 Years 100

Probability, %

80 60 40 20

(95% CI, 0.60-0.83)

0

+ Censoring times – Jakafi

No. of responders/events/censor: 66/16/50 0

No. at risk Events

12

24

36

48

60

72

84

96

108 120 132 144 156 168 180 192 204 216 228 240

Duration of Response, wk

252 264

66 66 66 66 66 66 64 63 62 60 58 58 56 56 56 56 56 55 54 54 53 51 49 49 48 48 48 44 44 44 42 42 42 41 40 39 39 39 39 38 28 5 3 1 0 0 0 0 0 0 0 0 1 2 4 5 5 6 6 6 6 6 7 8 8 9 10 10 10 10 10 10 12 12 12 14 14 14 15 15 16 16 16 16 16 16 16 16 16 16

Analysis was conducted in week 32 Hct control responders, beginning at week 3213 Progression events for the evaluation of duration of absence of phlebotomy eligibility included first of 2 consecutive Hct assessments that confirms phlebotomy eligibility, death, or development of MF or acute leukemia15 Reprinted from The Lancet Haematology, 7(3), Kiladjian J-J, Zachee P, Hino M, Long-term efficacy and safety of ruxolitinib versus best available therapy in polycythaemia vera (RESPONSE): 5-year follow up of a phase 3 study, e226-e237, Copyright 2020, with permission from Elsevier.

Exploratory Endpoint RESPONSE was an open-label trial and, therefore, not designed to evaluate differences in symptoms11 Patient-reported outcomes were assessed using the MPN-SAF symptom diary. The MPN-SAF diary was administered daily in an electronic diary format to score 14 disease-related symptoms on a scale of 0 (absent) to 10 (worst possible). At baseline, median TSS was 23.4 (range, 0-106) in the group receiving Jakafi and 33.3 (range, 0-118) in the group receiving BAT.12,15

Median Percent Change in Symptom Score From Baseline to Week 3212a Median Change in Symptom Score From Baseline to Week 32, %

40 20

0.4%

0

-4.2% -2.1%

-20

-49.6%

10.9%

5%

-41.8%

-44%

-51.5%

-61.1%

Jakafi BAT

17.2% 15.7% 0%

0%

1.4%

-37.1%

-64.1%

-80

-65.9%

-80.2% -94.9%

-100

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Itc

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-93.9%

-99.5% -100% he

Ac

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Nig

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S Cytokine Symptoms

a

7.9%

-4.4%

-40 -60

16.7%

11.1%

3.9%

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Wh

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Aw

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Pro

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Hyperviscosity Symptoms

At week 32, 49% (36/74) of patients receiving Jakafi and 5% (4/81) of patients receiving BAT had at least a 50% reduction in the 14-item MPN-SAF TSS12 Patients receiving Jakafi had reductions in all symptom clusters reported, whereas patients receiving BAT had an increase in scores of many symptoms12 From The New England Journal of Medicine, Vannucchi AM, Kiladjian JJ, Griesshammer M, et al, Ruxolitinib versus Standard Therapy for the Treatment of Polycythemia Vera, 372(5), 426-435. Copyright © 2015 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.

Patients with data at both baseline (value >0) and week 32 were included in this analysis. Negative values indicate a reduction in the severity of symptoms.12

Intervene with Jakafi in your appropriate patients with advanced PV INTERVENEJAKAFI.COM blockers) in patients with rheumatoid arthritis, a condition for which Jakafi is not indicated. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Jakafi particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur • Another JAK-inhibitor has increased the risk of thrombosis, including deep venous thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which Jakafi is not indicated.

In patients with myelofibrosis (MF) and polycythemia vera (PV) treated with Jakafi in clinical trials, the rates of thromboembolic events were similar in Jakafi and control treated patients. Patients with symptoms of thrombosis should be promptly evaluated and treated appropriately • Another JAK-inhibitor has increased the risk of lymphoma and other malignancies excluding NMSC (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which Jakafi is not indicated. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Jakafi, particularly in patients with a known secondary malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers • In myelofibrosis and polycythemia vera, the most common nonhematologic adverse reactions (incidence ≥15%) were bruising, dizziness, headache, and diarrhea. In acute graft-versus-host disease, the most common nonhematologic adverse reactions (incidence >50%) were infections (pathogen not specified) and edema. In chronic graft-versus-host disease,

the most common nonhematologic adverse reactions (incidence ≥20%) were infections (pathogen not specified) and viral infections • Avoid concomitant use with fluconazole doses greater than 200 mg.

Dose modifications may be required when administering Jakafi with fluconazole doses of 200 mg or less, or with strong CYP3A4 inhibitors, or in patients with renal or hepatic impairment. Patients should be closely monitored and the dose titrated based on safety and efficacy • Use of Jakafi during pregnancy is not recommended and should only be used if the potential benefit justifies the potential risk to the fetus. Women taking Jakafi should not breastfeed during treatment and for 2 weeks after the final dose Please see Brief Summary of Full Prescribing Information for Jakafi on the following pages. To learn more about Jakafi, visit HCP.Jakafi.com References: 1. Barosi G, et al. Br J Haematol. 2010;148(6):961-963.

2. Parasuraman S, et al. Exp Hematol Oncol. 2016;5:3. 3. Mascarenhas J. Clin Lymphoma Myeloma Leuk. 2016;16 Suppl:S124-S129. 4. Rumi E, et al. Blood.

2017;129(6):680-692. 5. Michiels JJ, et al. World J Hematol. 2013;2(3):71-88.

6. Michiels JJ. World J Crit Care Med. 2015;4(3):230-239. 7. Marchioli R, et al.

N Engl J Med. 2013;368(1):22-33. 8. Barbui T, et al. Blood. 2015;126(4):560-561.

9. Emanuel RM, et al. J Clin Oncol. 2012;30(33):4098-4103. 10. Verstovsek S, et al.

Cancer. 2014;120(4):513-520. 11. Jakafi Prescribing Information. Wilmington, DE: Incyte Corporation. 12. Vannucchi AM, et al. N Engl J Med. 2015;372(5):426-435.

13. Kiladjian J-J, et al. Lancet Haematol. 2020;7(3):e226-e237. 14. Kiladjian J-J, et al.

Lancet Haematol. 2020;7(Suppl):1-18. 15. Data on file. Incyte Corporation. Wilmington, DE. Jakafi and the Jakafi logo are registered trademarks of Incyte. © 2022, Incyte Corporation. MAT-JAK-03757 01/22 Spring 2022

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The safetyThe of Jakafi safetywas of Jakafi assessed was in assessed 617 in 617 following adverse followingevents adverse after events discontinuing after discontinuing Jakafi: fever, Jakafi:Myelofibrosis fever, Myelofibrosis patients inpatients six clinical in six studies clinical with studies a median with duration a medianofduration of respiratoryrespiratory distress, hypotension, distress, hypotension, DIC, or multi-organ DIC, or multi-organ follow-up offollow-up 10.9 months, of 10.9 including months,301 including patients 301 with patients MF inwith MF in failure. If one failure. or more If oneoforthese moreoccur of these afteroccur discontinuation after discontinuation 3 studies.

Phase 3Instudies. these two In these Phasetwo 3 studies, Phase 3 studies, of, or whileof,tapering or whilethe tapering dose ofthe Jakafi, dose evaluate of Jakafi,for evaluate and fortwo andPhasetwo had patients a median had duration a medianofduration exposure of to exposure Jakafi ofto Jakafi of treat any intercurrent treat any intercurrent illness andillness consider andrestarting consider or restartingpatients or 9.5 months9.5 (range months 0.5(range to 17 months), 0.5 to 17with months), 89% with 89% the dose ofthe Jakafi. dose Instruct of Jakafi. patients Instructnot patients to not to BRIEF SUMMARY: BRIEF SUMMARY: For Full Prescribing For Full Prescribing Information, Information,increasingincreasing of patients of treated patients for treated more than for more 6 months thanand 6 months 25% treated and 25% treated interrupt orinterrupt discontinue or discontinue Jakafi therapy Jakafi without therapy consulting without consulting see package seeinsert. package insert. for more 12 months. than 12One months. hundred Oneand hundred elevenand (111) eleven (111) their physician.

When discontinuing When discontinuing or interrupting or interrupting for more than INDICATIONS INDICATIONS AND USAGE AND Myelofibrosis USAGE Myelofibrosis Jakafi is Jakafi is their physician. patients started patients treatment started treatment at 15 mg twice at 15 daily mg twice and 190 daily and 190 therapy Jakafiwith for reasons Jakafi forother reasons thanother than indicated for indicated treatment for of treatment intermediate of intermediate or high-riskor high-risk therapy with patients at 20 started mg twice at 20 daily. mg twice In patients daily. Instarting patients starting thrombocytopenia thrombocytopenia or neutropenia or neutropenia [see Dosage [see and Dosage and patients started myelofibrosis myelofibrosis (MF), including (MF),primary including MF,primary MF, with 15 mgwith twice 15 daily mg twice (pretreatment daily (pretreatment platelet platelet Administration Administration (2.7) in Full(2.7) Prescribing in Full Prescribing Information], Information],treatment treatment post-polycythemia post-polycythemia vera MF and vera post-essential MF and post-essential 209/L) mgand twice 20 daily mg twice daily counts counts to 200 of 100 × 10 to9/L) 200and × 10 consider tapering considerthe tapering dose ofthe Jakafi dosegradually of Jakafi rather gradually thanrather than of 100 thrombocythemia thrombocythemia MF in adults.

MFPolycythemia in adults. Polycythemia Vera JakafiVera Jakafi (pretreatment (pretreatment platelet counts platelet greater counts than greater 200 ×than 109/L), 200 × 109/L), discontinuing discontinuing abruptly.

Non-Melanoma abruptly.

Non-Melanoma Skin Cancer Skin Cancer is indicatedisfor indicated treatment for of treatment polycythemia of polycythemia vera (PV) invera (PV) in 65% and 25% 65%ofand patients, 25% ofrespectively, patients, respectively, required arequired dose a dose (NMSC) Non-melanoma (NMSC) Non-melanoma skin cancers skin including cancers basal including cell, basal cell, adults whoadults have had whoan have inadequate had an inadequate response toresponse or are to or are reduction below reduction the below startingthe dose starting withindose the within first 8 the weeks first 8 weeks cell, and Merkel cell, and cellMerkel carcinoma cell carcinoma have occurred have occurred intolerant of intolerant hydroxyurea. of hydroxyurea.

Acute Graft-Versus-Host Acute Graft-Versus-Hostsquamoussquamous of therapy.ofIntherapy. a double-blind, In a double-blind, randomized, randomized, placebo- placebopatients with treated Jakafi.with Perform Jakafi.periodic Performskin periodic skin Disease Jakafi Disease is indicated Jakafi isfor indicated treatment for of treatment steroid- of steroid- in patientsintreated controlled study of Jakafi, study among of Jakafi, theamong 155 patients the 155 patients Lipid Elevations Lipid Elevations Treatment Treatment with Jakafiwith hasJakafi has controlled refractory acute refractory graft-versus-host acute graft-versus-host disease (aGVHD) diseasein(aGVHD) adult inexaminations. adult examinations. treated with treated Jakafi,with theJakafi, most frequent the mostadverse frequentreactions adverse reactions been associated been associated with increases with in increases lipid parameters in lipid parameters and pediatric andpatients pediatric12patients years and 12 older. years Chronic and older.GraftChronic Graftwere thrombocytopenia were thrombocytopenia and anemia and [see anemia Table [see 2]. Table 2]. including total including cholesterol, total cholesterol, low-density low-density lipoproteinlipoprotein (LDL) (LDL) Versus-Host Versus-Host Disease Jakafi Disease is indicated Jakafi isfor indicated treatment for of treatment of cholesterol,cholesterol, and triglycerides and triglycerides [see Adverse [seeReactions Adverse Reactions (6.1) Thrombocytopenia, (6.1) Thrombocytopenia, anemia andanemia neutropenia and neutropenia are dose-related are dose-related chronic graft-versus-host chronic graft-versus-host disease (cGVHD) diseaseafter (cGVHD) failureafter of failure of in Full Prescribing in Full Prescribing Information].

Information].

The effect The of these effectlipid of these effects. lipid Theeffects. three most The three frequent most nonhematologic frequent nonhematologic adverse adverse one or twoone linesoroftwo systemic lines oftherapy systemic in therapy adult andinpediatric adult and pediatric parameterparameter elevations elevations on cardiovascular on cardiovascular morbidity and morbidity and reactions were reactions bruising, weredizziness bruising,and dizziness headache and[see headache [see patients 12patients years and 12 older. years and older. mortality has mortality not been hasdetermined not been determined in patientsintreated patients treated Table 1]. Discontinuation Table 1]. Discontinuation for adversefor events, adverse regardless events, regardless of of CONTRAINDICATIONS CONTRAINDICATIONS None.

None. with Jakafi.with Assess Jakafi. lipid Assess parameters lipid parameters approximately approximately 8-12 8-12 was causality, causality, observed wasinobserved 11% of patients in 11% of treated patients withtreated Jakafiwith Jakafi WARNINGS WARNINGS AND PRECAUTIONS AND PRECAUTIONS Thrombocytopenia, Thrombocytopenia, weeks following weeks initiation followingofinitiation Jakafi therapy. of JakafiMonitor therapy. and Monitorand and11% ofand patients 11% of treated patients withtreated placebo. with Table placebo.

1 presents Table 1 presents Anemia and Anemia Neutropenia and Neutropenia Treatment Treatment with Jakafiwith canJakafi can treat according treat according to clinical guidelines to clinical guidelines for the management for the management the most common the mostnonhematologic common nonhematologic adverse reactions adverse reactions cause thrombocytopenia, cause thrombocytopenia, anemia and anemia neutropenia. and neutropenia. [see [see of hyperlipidemia. of hyperlipidemia.

Major Adverse MajorCardiovascular Adverse Cardiovascularoccurring inoccurring patients who in patients received whoJakafi received in theJakafi double-blind, in the double-blind, Adverse Reactions Adverse Reactions (6.1) in Full(6.1) Prescribing in Full Prescribing Information].

Information].

Events (MACE) EventsAnother (MACE)JAK-inhibitor Another JAK-inhibitor has increased has increased the the placebo-controlled placebo-controlled study during study randomized during randomized treatment. treatment.

Manage thrombocytopenia Manage thrombocytopenia by reducing bythe reducing dose orthe dose orrisk of MACE, riskincluding of MACE,cardiovascular including cardiovascular death, myocardial death, myocardial Table 1: Myelofibrosis: Table 1: Myelofibrosis: Nonhematologic Nonhematologic Adverse Adverse temporarilytemporarily interruptinginterrupting Jakafi. Platelet Jakafi. transfusions Platelet transfusions may may infarction, infarction, and strokeand (compared stroke (compared to those treated to those with treated with ReactionsReactions OccurringOccurring in Patientsinon Patients Jakafi on in Jakafi in be necessary be necessary [see Dosage [see and Dosage Administration and Administration (2) in Full (2) inTNF Fullblockers) TNF inblockers) patientsinwith patients rheumatoid with rheumatoid arthritis, a arthritis, a the Double-blind, the Double-blind, Placebo-controlled Placebo-controlled Study Study PrescribingPrescribing Information].

Information].

Patients developing Patients developing anemia may anemia may for condition condition which Jakafi for which is not Jakafi indicated. is not indicated.

Consider the Consider the During Randomized During Randomized TreatmentTreatment require blood require transfusions blood transfusions and/or dose and/or modifications dose modifications of of benefits and benefits risks for and the risks individual for the patient individual prior patient to prior to 9 Jakafi Jakafi Placebo Placebo /L) Jakafi. Severe Jakafi. neutropenia Severe neutropenia (ANC less than (ANC0.5 less×than 109/L) 0.5 × 10initiating orinitiating continuing or continuing therapy with therapy Jakafiwith particularly Jakafi particularly in in (N=155) (N=155) (N=151) (N=151) was generally was reversible generally reversible by withholding by withholding Jakafi untilJakafi untilpatients who patients are current who are or current past smokers or pastand smokers patients and patients All GradeAll Grade GradeAllGrade GradeAll Grade Grade Grade recovery. Perform recovery.a Perform pre-treatment a pre-treatment complete blood complete count blood count with other with cardiovascular other cardiovascular risk factors. risk Patients factors.should Patients be should be 4 Adverse AdverseGradesa 3Grades4a 3Grades4 3Grades4 3 (CBC) and (CBC) monitor andCBCs monitor everyCBCs 2 to every 4 weeks 2 tountil 4 weeks dosesuntil doses informed about informed the symptoms about the symptoms of serious of cardiovascular serious cardiovascular Reactions Reactions(%) (%) (%)(%) (%)(%) (%)(%) (%)(%) (%) (%) are stabilized, are stabilized, and then as and clinically then asindicated clinically [see indicated [see events andevents the steps and to thetake steps if they to take occur. if they Thrombosis occur. Thrombosis b Bruising Bruisingb 23 < 1 23 0 < 1 15 0 0 15 0 0 0 Dosage and Dosage Administration and Administration (2) in Full Prescribing (2) in Full Prescribing Another JAK-inhibitor Another JAK-inhibitor has increased has increased the risk of the risk of 0 Dizzinessc Dizzinessc 18 < 1 18 0 < 1 7 0 0 7 0 0 Information].

Information].

Risk of Infection Risk of Serious Infection bacterial, Serious bacterial, thrombosis, thrombosis, including deep including venous deep thrombosis venous thrombosis (DVT), (DVT), mycobacterial, mycobacterial, fungal andfungal viral infections and viral infections have occurred have occurred 0 15 0 0 5 0 0 5 0 0 0 pulmonarypulmonary embolism embolism (PE), and arterial (PE), and thrombosis arterial thrombosis Headache Headache 15 [see Adverse [seeReactions Adverse Reactions (6.1) in Full(6.1) Prescribing in Full Prescribing (compared(compared Urinary TractUrinary Tract to those treated to those with treated TNF blockers) with TNF inblockers) patientsin patients 0 9 0 0 5 0 <1 5<1 <1 <1 d Infections Infectionsd 9 Information].

Information].

Delay starting Delay therapy starting with therapy Jakafiwith untilJakafi untilwith rheumatoid with rheumatoid arthritis, a arthritis, conditiona for condition which Jakafi for which is Jakafi is e e Weight Gain Weight Gain 7 < 1 7 0 <11 0 <1 1 0 <1 0 active serious active infections serious infections have resolved. haveObserve resolved.patients Observe patients not indicated. not indicated.

In patientsInwith patients MF and with PVMF treated and PV with treated with receiving Jakafi receiving for signs Jakafiand for signs symptoms and symptoms of infectionofand infection and in clinical 0 5 0 0 <1 0 0 <10 0 0 Jakafi Jakafi trials, in clinical the rates trials,ofthe thromboembolic rates of thromboembolicFlatulence Flatulence 5 f manage promptly. manage Use promptly. activeUse surveillance active surveillance and and Herpes Zoster Herpes Zoster 2f 0 2 0 0 <1 0 0 <10 0 0 events were events similar were in Jakafi similarand in Jakafi controland treated control patients. treated patients. prophylactic prophylactic antibioticsantibiotics according according to clinical guidelines. to clinical guidelines. a Patients with Patients symptoms with symptoms of thrombosis of thrombosis should be should be a National Cancer National Institute Cancer Common Institute Terminology CommonCriteria Terminology for Adverse CriteriaEvents for Adverse Events Tuberculosis Tuberculosis Tuberculosis Tuberculosis infection has infection been reported has beeninreported in (CTCAE), version (CTCAE), 3.0 version 3.0 promptly evaluated promptly evaluated and treatedand appropriately. treated appropriately.

SecondarySecondary b b includes contusion, includes ecchymosis, contusion,hematoma, ecchymosis,injection hematoma, site hematoma, injection site hematoma, patients receiving patients Jakafi. receiving Observe Jakafi.patients Observereceiving patients receiving Malignancies Malignancies Another JAK-inhibitor Another JAK-inhibitor has increased has increased the the periorbital hematoma, periorbital vessel hematoma, puncture vessel site puncture hematoma, siteincreased hematoma, tendency increased tendency Jakafi for signs Jakafiand for signs symptoms and symptoms of active tuberculosis of active tuberculosis and riskand of lymphoma risk of lymphoma and other malignancies and other malignancies excluding excluding to bruise, petechiae, to bruise, purpura petechiae, purpura manage promptly. manage Prior promptly. to initiating Prior toJakafi, initiating patients Jakafi, patientsNMSC (compared c c NMSC (compared to those treated to those with treated TNF blockers) with TNF inblockers) in dizziness, includes includes postural dizziness, dizziness, postural vertigo, dizziness, balance vertigo, disorder, balance Meniere’s disorder, Meniere’s should be should evaluated be evaluated for tuberculosis for tuberculosis risk factors, risk and factors, and Disease, labyrinthitis Disease, labyrinthitis patients with patients rheumatoid with rheumatoid arthritis, a arthritis, conditiona for condition which for which d d includes urinary includes tract infection, urinary tract cystitis, infection, urosepsis, cystitis, urinary urosepsis, tract infection urinary tract infection those at higher thoserisk at higher shouldrisk be should tested for be latent testedinfection. for latent infection.

Jakafi is not Jakafi indicated. is not indicated.

Patients who Patients are current who are or current past or past bacterial, kidney bacterial, infection, kidney pyuria, infection, bacteria pyuria, urine,bacteria bacteriaurine, urinebacteria identified, urine identified, Risk factors Risk include, factorsbutinclude, are notbut limited are not to, limited prior residence to, prior residence smokers are smokers at additional are at additional increased increased risk. Consider risk.the Consider the nitrite urine present nitrite urine present in or travelintoorcountries travel to with countries a highwith prevalence a high prevalence of of benefits and e benefits risks for andthe risks individual for the patient individual prior patient to prior to e includes weight includes increased, weight abnormal increased, weight abnormal gain weight gain f f tuberculosis, tuberculosis, close contact close with contact a person withwith a person activewith active includes herpes includes zoster herpes and post-herpetic zoster and post-herpetic neuralgia neuralgia initiating orinitiating continuing or continuing therapy with therapy Jakafi,with particularly Jakafi, particularly in in tuberculosis, tuberculosis, and a history andofa active historyoroflatent activetuberculosis or latent tuberculosis Description of Selected of Adverse SelectedReactions: Adverse Reactions: Anemia Anemia patients with patients a known withsecondary a known secondary malignancymalignancy (other than(otherDescription than where an adequate where an course adequate of treatment course of treatment cannot be cannot be a successfully Phase the two 3 clinical Phasestudies, 3 clinicalmedian studies, time median to time to a successfully treated NMSC), treated patients NMSC),who patients develop whoa developInathe two In confirmed.confirmed.

For patients Forwith patients evidence withofevidence active oroflatent active or latent onset CTCAE of first Grade CTCAE 2 orGrade higher2anemia or higher was anemia was malignancy, malignancy, and patients andwho patients are current who are or current past or past onset of first tuberculosis, tuberculosis, consult a physician consult a with physician expertise with inexpertise the in the approximately approximately 6 weeks. One 6 weeks. patientOne (< patient 1%) discontinued (< 1%) discontinued smokers. ADVERSE smokers. ADVERSE REACTIONS REACTIONS The following The clinically following clinically treatment treatment of tuberculosis of tuberculosis before starting before Jakafi. starting TheJakafi. Thesignificantsignificant treatment treatment because ofbecause anemia.ofInanemia. patientsInreceiving patients Jakafi, receiving Jakafi, adverse reactions adverse are reactions discussed are discussed in greater in greater decision todecision continuetoJakafi continue during Jakafi treatment during treatment of active of active mean decreases mean decreases in hemoglobin in hemoglobin reached a reached nadir of a nadir of detail in other detail sections in otherofsections the labeling: of the• labeling: Thrombocytopenia, • Thrombocytopenia, tuberculosis tuberculosis should be should based on be the based overall on the risk-benefit overall risk-benefit approximately approximately 1.5 to 2.0 g/dL 1.5 tobelow 2.0 g/dL baseline belowafter baseline 8 to 12 after 8 to 12 Anemia and Anemia Neutropenia and Neutropenia [see Warnings [seeand Warnings Precautions and Precautions determination. determination.

Progressive Progressive Multifocal Multifocal weeks of therapy weeks of and therapy then gradually and then recovered gradually recovered to reach a to reach a (5.1) in Full(5.1) Prescribing in Full Prescribing Information] Information] • Risk of Infection • Risk of Infection Leukoencephalopathy Leukoencephalopathy Progressive Progressive multifocal multifocal new steadynew state steady that was stateapproximately that was approximately 1.0 g/dL below 1.0 g/dL below [see Warnings [seeand Warnings Precautions and Precautions (5.2) in Full(5.2) Prescribing in Full Prescribing leukoencephalopathy leukoencephalopathy (PML) has (PML) occurred haswith occurred Jakafiwith Jakafi baseline. pattern This waspattern observed wasinobserved patientsinregardless patients regardless Information] Information] • Symptom• Exacerbation Symptom Exacerbation Following Following baseline. This treatment.treatment.

If PML is suspected, If PML is suspected, stop Jakafistop andJakafi evaluate. and evaluate. of whetherofthey whether had received they hadtransfusions received transfusions during therapy. during therapy.

InterruptionInterruption or Discontinuation or Discontinuation of Treatment of Treatment with Jakafiwith Jakafi Herpes Zoster Herpes Advise Zoster patients Adviseabout patients earlyabout signsearly and signs and[see Warnings In the randomized, In the randomized, placebo-controlled placebo-controlled study, 60%study, of 60% of [seeand Warnings Precautions and Precautions (5.3) in Full(5.3) Prescribing in Full Prescribing symptomssymptoms of herpes zoster of herpes andzoster to seek and treatment to seek treatment as as patients treated patients with treated Jakafiwith andJakafi 38% ofand patients 38% ofreceiving patients receiving InformationInformation ] • Non-Melanoma ] • Non-Melanoma Skin Cancer Skin [see Cancer Warnings [see Warnings early as possible early asif possible suspected. if suspected.

Hepatitis BHepatitis HepatitisBBHepatitis viral and B viral placebo received placebored received blood cell red transfusions blood cell transfusions during during Precautions and Precautions (5.4) in Full(5.4) Prescribing in Full Prescribing Information] Information] load (HBV-DNA load (HBV-DNA titer) increases, titer) increases, with or without with or associated without associated randomized randomized treatment.treatment.

Among transfused Among transfused patients, the patients, the • Lipid Elevations • Lipid Elevations [see Warnings [see and Warnings Precautions and Precautions (5.5) (5.5) elevations elevations in alanine in aminotransferase alanine aminotransferase and aspartate and aspartate median number medianofnumber units transfused of units transfused per monthper wasmonth 1.2 was 1.2 in Full Prescribing in Full Prescribing Information] Information] • Major Adverse • Major Adverse aminotransferase, aminotransferase, have beenhave reported beeninreported patientsinwith patients with in patientsintreated patients with treated Jakafiwith andJakafi 1.7 in and placebo 1.7 intreated placebo treated Cardiovascular Cardiovascular Events (MACE) Events [see(MACE) Warnings [seeand Warnings Precautions and Precautions chronic HBV chronic infections HBV infections taking Jakafi. taking TheJakafi. effect The of Jakafi effect of Jakafi patients. Thrombocytopenia In the two In Phase the two 3 clinical Phase 3 clinical (5.6) in Full(5.6) Prescribing in Full Prescribing Information]Information] • Thrombosis • Thrombosis [see [seepatients. Thrombocytopenia on viral replication on viral replication in patientsinwith patients chronic with HBV chronic infection HBV infection patientsinwho patients developed who developed Grade 3 orGrade 4 3 or 4 Warnings and Warnings Precautions and Precautions (5.7) in Full(5.7) Prescribing in Full Prescribing studies, instudies, is unknown. is unknown.

Patients with Patients chronic with HBV chronic infection HBVshould infection should thrombocytopenia, the medianthe time median to onset timewas to onset was Information] Information] • Secondary • Secondary Malignancies Malignancies [see Warnings [seeand Warnings and thrombocytopenia, be treatedbe andtreated monitored and monitored according according to clinical guidelines. to clinical guidelines. approximately approximately 8 weeks. Thrombocytopenia 8 weeks. Thrombocytopenia was generally was generally PrecautionsPrecautions (5.8) in Full(5.8) Prescribing in Full Prescribing Information].

Information].

Clinical Clinical SymptomSymptom Exacerbation Exacerbation FollowingFollowing Interruption Interruption or or reversible reversible with dose with reduction dose or reduction dose interruption. or dose interruption.

Trials Experience Trials Experience Because clinical Because trials clinical are conducted trials are conducted Discontinuation Discontinuation of Treatment of Treatment with Jakafi with Following Jakafi Following The median The time median to recovery time toofrecovery platelet of counts platelet above counts above under widely under varying widely conditions, varying conditions, adverse reaction adverserates reaction rates discontinuation discontinuation of Jakafi, symptoms of Jakafi, symptoms from from 149/L days. wasPlatelet 14 days. transfusions Platelet transfusions were were 50 × 109/L50was × 10 observed in observed the clinical in the trials clinical of a drug trialscannot of a drug be cannot directlybe directly myeloproliferative myeloproliferative neoplasmsneoplasms may returnmay to pretreatment return to pretreatment administered administered to 5% of patients to 5% ofreceiving patients Jakafi receiving and to Jakafi 4% and to 4% compared compared to rates in to therates clinical in the trials clinical of another trials ofdrug another drug levels overlevels a period overofaapproximately period of approximately one week.one Some week. Some patients control receiving regimens. control regimens.

Discontinuation Discontinuation and may not andreflect may not the reflect rates observed the rates in observed practice.in practice. of patientsofreceiving patients with patients MF have withexperienced MF have experienced one or more oneoforthemore of the

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of treatment ofbecause treatment ofbecause thrombocytopenia of thrombocytopenia occurred inoccurred Table in Table 4: Polycythemia Vera: Laboratory Selected Laboratorydrugs [seedrugs 4: Polycythemia Vera: Selected Clinical [see Studies Clinical (14.4) Studies in full (14.4) Prescribing in full Prescribing < 1% of patients < 1% ofreceiving patients Jakafi receiving and Jakafi < 1% of andpatients < 1% of patients Abnormalities in the Open-Label, Abnormalities in the Open-Label, Active- ActiveInformation]; Information]; sixty-five patients sixty-fivecrossed patientsover crossed from over best from best receiving control receiving regimens. control regimens.

Patients with Patients a platelet withcount a platelet count controlledcontrolled Study up to Study Week up32 to of Week 32 of available therapy available to therapy treatment to treatment with Jakafi,with for Jakafi, a total of for a total of 9 9 9 9 a a to ×200 to /L 200 before × 10starting /L before Jakafi starting had Jakafi had of 100 × 10 of /L 100 10×/L10 Randomized Randomized TreatmentTreatment 230 patients 230treated patients with treated Jakafi.with TheJakafi. median The duration medianofduration of a higher frequency a higher frequency of Grade 3oforGrade 4 thrombocytopenia 3 or 4 thrombocytopenia exposure toexposure Jakafi fortothe Jakafi study forwas the study 49.7 weeks was 49.7 (range, weeks 0.7(range, 0.7 Jakafi JakafiBest Available Best Available compared compared to patientstowith patients a platelet with count a platelet greater count than greater than to 144.9 weeks) to 144.9 in the weeks) Jakafi in arm. the Jakafi One hundred arm. Oneand hundred nine and nine (N=110) (N=110) Therapy (N=111) Therapy (N=111) 9 /L (17% 7%). versus Neutropenia 7%). Neutropenia In the two In the two 200 × 109/L 200(17% × 10versus (47%) were patients on Jakafi werefor onatJakafi least for 1 year. at least There 1 year. wereThere were All GradeAllGradeGradeAllGrade GradeAll GradeGrade(47%) Gradepatients Phase 3 clinical Phasestudies, 3 clinical 1%studies, of patients 1% ofreduced patientsorreduced stoppedor stopped five fatal reactions adversetoreactions Jakafi, including to Jakafi,1including from toxic1 from toxic LaboratoryLaboratory Gradesb 3Grades4b Grades 3 4 3Grades 4 3 five 4fatal adverse Jakafi because Jakafiofbecause neutropenia. of neutropenia.

Table 2 provides Table 2the provides the Parameter Parameter (%) (%) (%)(%) (%)(%) (%)(%) (%)(%) (%)epidermal necrolysis epidermal and necrolysis 4 fromand neutropenia, 4 from neutropenia, anemia and/or anemia and/or (%) frequency frequency and severity and of severity clinical hematology of clinical hematology abnormalities abnormalities thrombocytopenia. thrombocytopenia.

An adverseAn reaction adverse resulting reactioninresulting treatment in treatment HematologyHematology reported forreported patientsforreceiving patientstreatment receiving with treatment Jakafiwith or Jakafi Anemia or discontinuation occurred inoccurred 18% of patients in 18% of treated patients withtreated with Anemia 72 < 1 72< 1 < 158 < 1 0 58 0 0 discontinuation 0 placebo in placebo the placebo-controlled in the placebo-controlled study. study.

Jakafi. An reaction adverse resulting reactioninresulting dose modification in dose modification Thrombocytopenia Thrombocytopenia 27 5 27< 1 5 24 < 1 3 24< 1 3 Jakafi. < 1 An adverse inoccurred 27%, andinan 27%, adverse and an reaction adverse resulting reactioninresulting in Table 2: Myelofibrosis: Table 2: Myelofibrosis: Worst Hematology Worst Hematology LaboratoryLaboratory NeutropeniaNeutropenia 3 0 3 < 1 0 10 < 1< 1 10 0 < 1occurred 0 treatment interruption treatment interruption occurred inoccurred 23%. Theinmost 23%.common The most common a Abnormalities Abnormalities in the Placebo-Controlled in the Placebo-Controlled Studya Study Chemistry Chemistry hematologic hematologic adverse reactions adverse(incidence reactions (incidence > 35%) are> 35%) are Jakafi Jakafi Placebo Placebo Hypercholesterolemia Hypercholesterolemia 35 0 35 0 0 8 0 0 8 0 0 anemia 0 andanemia thrombocytopenia. and thrombocytopenia.

The most common The most common (N=155) (N=155) (N=151) (N=151) Elevated ALTElevated ALT25 < 1 25 0 < 116 0 0 16 0 0 nonhematologic 0 nonhematologic adverse reactions adverse(incidence reactions (incidence ≥ 20%) are≥ 20%) are All GradeAllGrade Grade AllGrade GradeAll Grade GradeElevated Grade ASTElevated AST23 0 23 0 0 23 0 < 1 23 0 < 1infections 0 (pathogen infections not (pathogen specified) not and specified) viral infection. and viralTable infection.

7 Table 7 b b Laboratory Laboratory Grades Grades 3 4 Grades 3 4 3Grades 4 3 4 presents most frequent the mostnonlaboratory frequent nonlaboratory adverse reactions adverse reactions Hypertriglyceridemia 15 0 15 0 0 13 0 0 13 0 0 presents 0 the Parameter Parameter(%) (%)(%)(%) (%)(%) (%)(%) (%)(%) (%) Hypertriglyceridemia (%) a a occurring to Cycleup 7 Day to Cycle 1 of 7randomized Day 1 of randomized treatment. treatment. values Presented are worst values Grade arevalues worst regardless Grade values of regardless baseline of baseline occurring up Thrombocytopenia Thrombocytopenia 70 9 70 4 9 31 4 1 31 0 1 b Presented 0 b National Cancer National Institute Cancer Common Institute Terminology CommonCriteria Terminology for Adverse CriteriaEvents, for Adverse Events, Table 7: Chronic Table 7: Graft-Versus-Host Chronic Graft-Versus-Host Disease: All-Grade Disease: All-Grade Anemia Anemia 96 34 96 11 3487 11 16 87 3 16 version 3 3.0 version 3.0 (≥ 10%) and (≥ 10%) Grades and 3-5Grades (≥ 3%)3-5 Nonlaboratory (≥ 3%) Nonlaboratory NeutropeniaNeutropenia19 5 19 2 5 4 2 < 1 4 1 < 1 Acute 1 Graft-Versus-Host Acute Graft-Versus-Host Disease In Disease a single-arm, In a single-arm, Adverse Reactions Adverse Reactions Occurring Occurring in PatientsininPatients the in the a a Presented values Presented are worst values Grade arevalues worst regardless Grade values of regardless baseline of baseline open-labelopen-label study, 71 adults study,(ages 71 adults 18-73 (ages years) 18-73 wereyears) were b b Open-Label, Open-Label, Active-controlled Active-controlled Study up to Study Cycleup to Cycle National Cancer National Institute Cancer Common Institute Terminology CommonCriteria Terminology for Adverse CriteriaEvents, for Adverse Events, treated with treated Jakafiwith for aGVHD Jakafi for failing aGVHD treatment failing with treatment with version 3.0 version 3.0 7 Day 1 of7Randomized Day 1 of Randomized TreatmentTreatment steroids with steroids or without with or other without immunosuppressive other immunosuppressive drugs drugs AdditionalAdditional Data fromData the Placebo-Controlled from the Placebo-Controlled Study Study Jakafi Jakafi Best Available Best Available [see Clinical [see Studies Clinical (14.3) Studies in Full (14.3) Prescribing in Full Prescribing Information].

Information].

• 25% of patients • 25% oftreated patients with treated Jakafiwith andJakafi 7% ofand patients 7% of patients (N = 165) (N =Therapy 165) (NTherapy = 158) (N = 158) duration medianofduration treatment of with treatment Jakafiwith wasJakafi 46 days was 46 days treated with treated placebo withdeveloped placebo developed newly occurring newly or occurring or The medianThe All Grade All All Grade Grade All Grade (range, 4-382 (range, days).

4-382 There days). wereThere no fatal were adverse no fatalreactions adverse reactions worseningworsening Grade 1 abnormalities Grade 1 abnormalities in alanine in transaminase alanine transaminase a Gradesa Grades ≥ 3 Grades ≥ 3 Grades ≥3 ≥3 to Jakafi.

An to adverse Jakafi. Anreaction adverseresulting reactioninresulting treatment in treatment (ALT). The (ALT). incidence The of incidence greater of than greater or equal thantoorGrade equal2to Grade 2 b b (%) (%) (%) (%)(%) (%) (%) (%) Adverse Reactions Adverse Reactions discontinuation occurred inoccurred 31% of patients. in 31% ofThe patients. most The most elevations elevations was 2% forwas Jakafi 2% with for Jakafi 1% Grade with 1% 3 and Grade no 3 anddiscontinuation no common adverse commonreaction adverseleading reaction to treatment leading to treatment Infections and Infections infestations and infestations Grade 4 ALT Grade elevations.

4 ALT elevations.

• 17% of patients • 17% oftreated patients with treated with discontinuation discontinuation was infection was(10%). infection Table (10%).

5 shows Tablethe 5 shows theInfections (pathogen Infections (pathogen Jakafi andJakafi 6% ofand patients 6% oftreated patients with treated placebo withdeveloped placebo developed 1545 4415 1644 16 adverse reactions adverseother reactions than other laboratory than laboratory abnormalities. abnormalities.not specified) not specified) 45 newly occurring newly or occurring worsening or worsening Grade 1 abnormalities Grade 1 abnormalities in in Viral infections Viral infections 28 5 28 23 5 5 23 5 Table 5: Acute Table Graft-Versus-Host 5: Acute Graft-Versus-Host Disease: Disease: aspartate transaminase aspartate transaminase (AST). The (AST). incidence The of incidence Grade 2of Grade 2 Musculoskeletal Musculoskeletal and connective and connective tissue disorders tissue disorders Nonhematologic Adverse Reactions Adverse Reactions OccurringOccurring AST elevations AST elevations was < 1%was for Jakafi < 1% with for Jakafi no Grade with3noorGrade 4 3 or 4 Nonhematologic Musculoskeletal Musculoskeletal pain 18pain 1 18 13 1 013 0 in Patients ≥ 15% ofinPatients the Open-Label, in the Open-Label, Single- SingleAST elevations.

AST elevations.

• 17% of patients • 17% oftreated patients with treated Jakafiwith andJakafi and in ≥ 15% of General disorders Generaland disorders administration and administration site conditions site conditions Cohort Study < 1% of patients < 1% oftreated patients with treated placebo withdeveloped placebo developed newly newly Cohort Study Pyrexia Pyrexia 16 2 16 9 2 19 1 occurring or occurring worsening or worsening Grade 1 elevations Grade 1 elevations in cholesterol. in cholesterol.

Jakafi (N=71) Jakafi (N=71) Fatigue Fatigue 13 1 13 10 1 210 2 The incidence The of incidence Grade 2ofcholesterol Grade 2 cholesterol elevations elevations was wasAdverse Reactions a a b b Adverse Reactions All Grades All (%)Grades Grade(%) 3-4 (%) Grade 3-4Edema (%) Edema 10 1 10 12 1 112 1 < 1% for Jakafi < 1% with for Jakafi no Grade with3noorGrade 4 cholesterol 3 or 4 cholesterol Infections (pathogen Infections (pathogen 55 Vascular disorders Vascular disorders elevations.elevations.

Polycythemia Polycythemia Vera In a randomized, Vera In a randomized, 55 41 41 not specified) not specified) Hypertension Hypertension 16 5 16 13 5 713 7 open-label,open-label, active-controlled active-controlled study, 110study, patients 110with patients PV with PV Edema Edema 51 51 13 13 HemorrhageHemorrhage 12 2 12 15 2 215 2 resistant toresistant or intolerant to or of intolerant hydroxyurea of hydroxyurea received Jakafi received Jakafi HemorrhageHemorrhage 49 49 20 20Respiratory,Respiratory, thoracic and thoracic mediastinal and mediastinal disorders disorders and 111 patients and 111received patientsbest received available besttherapy available [see therapy [see Fatigue Fatigue 37 37 14 14 Cough Cough 13 0 13 8 0 08 0 Clinical Studies Clinical (14.2) Studies in Full (14.2) Prescribing in Full Prescribing Information].

Information].

Bacterial infections Bacterial infections 32 32 28 28 Dyspnea Dyspnea 11 1 11 8 1 18 1 The most frequent The mostadverse frequentreaction adversewas reaction anemia. was anemia. Dyspnea Dyspnea 32 32 7 7 Gastrointestinal Gastrointestinal disorders disorders Discontinuation Discontinuation for adverseforevents, adverse regardless events, regardless of of Viral infections Viral infections 31 31 14 14 Nausea Nausea 12 0 12 13 0 213 2 causality, was causality, observed was in observed 4% of patients in 4% oftreated patients with treated with ThrombosisThrombosis 25 25 11 11 Diarrhea Diarrhea 10 1 10 13 1 113 1 Jakafi. Table Jakafi.

3 presents Table 3the presents most frequent the mostnonhematologic frequent nonhematologic a Diarrhea Diarrhea 24 24 7 7 a National Cancer National Institute Cancer Common Institute Terminology CommonCriteria Terminology for Adverse CriteriaEvents for Adverse Events adverse reactions adverseoccurring reactions up occurring to Weekup32.to Week 32.

(CTCAE), 4.03 version 4.03 Rash Rash 23 23 3 (CTCAE), version 3 b Grouped that areterms composites that areofcomposites applicable adverse of applicable reaction adverse terms. reaction terms.

Table 3: Polycythemia Table 3: Polycythemia Vera: Nonhematologic Vera: Nonhematologic Adverse Adverse 21 4 b Grouped terms Headache Headache 21 4 ReactionsReactions OccurringOccurring in ≥ 5% ofinPatients ≥ 5% ofon Patients on Clinicallylaboratory relevant laboratory abnormalities abnormalities are shownare in shown in 20 13 13Clinically relevant HypertensionHypertension 20 Jakafi in the Jakafi Open-Label, in the Open-Label, Active-controlled Active-controlled 16 0 Table 8. Table 8.

Dizziness Dizziness 16 0 a a Study up to Study Week up32 toof Week Randomized 32 of Randomized TreatmentTreatment Selected laboratory Selected abnormalities laboratory abnormalities are listed in Table are listed 6 below in Table 6 below Table 8: Chronic Table 8:Graft-Versus-Host Chronic Graft-Versus-Host Disease: Selected Disease: Selected b b National Cancer National Institute Cancer Common Institute Terminology CommonCriteria Terminology for Adverse Criteria Events for Adverse Events Laboratory Laboratory Abnormalities Abnormalities in the Open-Label, in the Open-Label, Jakafi Jakafi Best Available Best Available (CTCAE), version (CTCAE), 4.03 version 4.03 (N=110) (N=110) Therapy (N=111) Therapy (N=111) Active-controlled Active-controlled Study up to Study Cycle up7toDay Cycle 1 7 Day 1 Selected laboratory Selected laboratory abnormalities abnormalities during treatment during treatment with with a a of Randomized of Randomized TreatmentTreatment Grade Grade All Grade All Grade All All Jakafi shownare in Table shown6.in Table 6.

3-4 a Grades 3-4 Grades 3-4 3-4 are Jakafi Gradesa Grades Jakafi Jakafi Best Available Best Available Adverse Reactions Adverse Reactions Table TableGraft-Versus-Host 6: Acute Graft-Versus-Host Disease: Selected Disease: Selected (%) (%) (%) (%) (%) (%) (%) (%) 6: Acute (N=165) (N=165) Therapy (N=158) Therapy (N=158) LaboratoryLaboratory Abnormalities Abnormalities WorseningWorsening from from Diarrhea Diarrhea 15 015 70 < 17 <1 All All All Grade Grade Grade All Grade Baseline inBaseline the Open-Label, in the Open-Label, Single Cohort Single Study Cohort Study Dizzinessb Dizzinessb 15 015 130 013 0 Gradesb Grades ≥ 3 bGrades ≥ 3 Grades ≥3 ≥3 c c Dyspnea Dyspnea 13 313 43 04 0 Test Test (%) Jakafi (N=71) Jakafi (N=71) LaboratoryLaboratory (%) (%) (%)(%) (%) (%) (%) Muscle Spasms Muscle Spasms 12 < 12 1 5< 1 05 0 HematologyHematology Worst grade Worst during grade treatment during treatment ConstipationConstipation 8 08 30 03 0 a a Anemia Anemia 82 1382 7513 875 8 (%) Grade (%) 3-4 (%) Grade 3-4 (%) All Grades All Grades Laboratory Laboratory Parameter Parameter d d Herpes Zoster Herpes Zoster 6 < 16 0< 1 00 0 Thrombocytopenia Thrombocytopenia27 1227 2312 923 9 Hematology Hematology Nausea Nausea 6 06 40 04 0 58 2058 5420 1754 17 e Anemia Anemia 75 75 45 45 NeutropeniaNeutropenia Weight GainWeight Gaine 6 06 < 10 0< 1 0 Thrombocytopenia Thrombocytopenia 75 75 61 61 Chemistry Chemistry Urinary TractUrinary Infections Tractf Infections 6 f 06 30 03 0 Hypercholesterolemia 88 1088 8510 885 8 Neutropenia Neutropenia 58 58 40 40 Hypercholesterolemia Hypertension Hypertension 5 < 15 3< 1 < 13 <1 Elevated AST Elevated AST 65 5 65 54 5 6 54 6 a a Chemistry Chemistry National Cancer National Institute Cancer Common Institute Terminology CommonCriteria Terminology for Adverse CriteriaEvents for Adverse Events Elevated ALTElevated ALT 73 1173 7111 1671 16 (CTCAE), version (CTCAE), 3.0 version 3.0 Elevated ALT Elevated ALT 48 48 8 8 b b includes dizziness includes and dizziness vertigo and vertigo Elevated ASTElevated AST 48 48 6 6 Gamma Gamma c c includes dyspnea includes and dyspnea dyspnea exertional and dyspnea exertional glutamyltransferase glutamyltransferase 81 4281 7542 3875 38 d d Hypertriglyceridemia Hypertriglyceridemia 11 11 1 1 increased increased includes herpes includes zoster herpes and post-herpetic zoster and post-herpetic neuralgia neuralgia e e a a includes weight includes increased weight andincreased abnormaland weight abnormal gain weight gain National Cancer National Institute Cancer Common Institute Terminology CommonCriteria Terminology for Adverse CriteriaEvents, for Adverse Events, Creatinine increased Creatinine increased 47 147 40 1 240 2 f f includes urinary includes tract infection urinary tract and cystitis infection and cystitis version 4.03 version 4.03 Elevated lipase Elevated lipase 38 1238 3012 930 9 Clinically relevant Clinicallylaboratory relevant laboratory abnormalities abnormalities are shownare shown Chronic Graft-Versus-Host Chronic Graft-Versus-Host Disease InDisease a PhaseIn3,a Phase 3, Elevated amylase Elevated amylase 35 835 25 8 425 4 in Table 4.in Table 4. randomized, randomized, open-label,open-label, multi-center multi-center study, 165study, patients 165 patients a a Presented values Presented are worst values Grade arevalues worst regardless Grade values of regardless baseline of baseline were treated were with treated Jakafiwith andJakafi 158 patients and 158were patients treated were treated b b National Cancer National Institute Cancer Common Institute Terminology CommonCriteria Terminology for Adverse CriteriaEvents, for Adverse Events, with best available with besttherapy available fortherapy cGVHD for failing cGVHD treatment failing treatment version 4.03 version 4.03 with steroids withwith steroids or without with or other without immunosuppressive other immunosuppressive Spring 2022

5

DRUG INTERACTIONS Fluconazole Concomitant use of Jakafi with fluconazole increases ruxolitinib exposure [see Clinical Pharmacology (12.3) in Full Prescribing Information], which may increase the risk of exposurerelated adverse reactions. Avoid concomitant use of Jakafi with fluconazole doses of greater than 200 mg daily. Reduce the Jakafi dosage when used concomitantly with fluconazole doses of less than or equal to 200 mg [see Dosage and Administration (2.5) in Full Prescribing Information]. Strong CYP3A4 Inhibitors Concomitant use of Jakafi with strong CYP3A4 inhibitors increases ruxolitinib exposure [see Clinical Pharmacology (12.3) in Full Prescribing Information], which may increase the risk of exposure-related adverse reactions. Reduce the Jakafi dosage when used concomitantly with strong CYP3A4 inhibitors except in patients with aGVHD or cGVHD [see Dosage and Administration (2.5) in Full Prescribing Information]. Strong CYP3A4 Inducers Concomitant use of Jakafi with strong CYP3A4 inducers may decrease ruxolitinib exposure [see Clinical Pharmacology (12.3) in Full Prescribing Information], which may reduce efficacy of Jakafi. Monitor patients frequently and adjust the Jakafi dose based on safety and efficacy [see Clinical Pharmacology (12.3) in Full Prescribing Information].

USE IN SPECIFIC POPULATIONS Pregnancy: Risk Summary When pregnant rats and rabbits were administered ruxolitinib during the period of organogenesis adverse developmental outcomes occurred at doses associated with maternal toxicity (see Data). There are no studies with the use of Jakafi in pregnant women to inform drug-associated risks. The background risk of major birth defects and miscarriage for the indicated populations is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The background risk in the U.S. general population of major birth defects is 2% to 4% and miscarriage is 15% to 20% of clinically recognized pregnancies. Data: Animal Data Ruxolitinib was administered orally to pregnant rats or rabbits during the period of organogenesis, at doses of 15, 30 or 60 mg/kg/day in rats and 10, 30 or 60 mg/kg/day in rabbits. There were no treatment-related malformations.

Adverse developmental outcomes, such as decreases of approximately 9% in fetal weights were noted in rats at the highest and maternally toxic dose of 60 mg/kg/day.

This dose results in an exposure (AUC) that is approximately 2 times the clinical exposure at the maximum recommended dose of 25 mg twice daily.

In rabbits, lower fetal weights of approximately 8% and increased late resorptions were noted at the highest and maternally toxic dose of 60 mg/kg/day. This dose is approximately 7% the clinical exposure at the maximum recommended dose. In a pre- and post-natal development study in rats, pregnant animals were dosed with ruxolitinib from implantation through lactation at doses up to 30 mg/kg/day. There were no drug-related adverse findings in pups for fertility indices or for maternal or embryofetal survival, growth and development parameters at the highest dose evaluated (34% the clinical exposure at the maximum recommended dose of 25 mg twice daily). Lactation: Risk Summary No data are available regarding the presence of ruxolitinib in human milk, the effects on the breast fed child, or the effects on milk production.

Ruxolitinib and/or its metabolites were present in the milk of lactating rats (see Data). Because many drugs are present in human milk and because of the potential for thrombocytopenia and anemia shown for Jakafi in human studies, discontinue breastfeeding during treatment with Jakafi and for two weeks after the final dose. Data: Animal Data Lactating rats were administered a single dose of [14C]-labeled ruxolitinib (30 mg/kg) on postnatal Day 10, after which plasma and milk samples were collected for up to 24 hours. The AUC for total radioactivity in milk was approximately 13-fold the maternal plasma AUC. Additional analysis showed the presence of ruxolitinib and several of its metabolites in milk, all at levels higher than those in maternal plasma.

Pediatric Use The safety and effectiveness of Jakafi for treatment of myelofibrosis or polycythemia vera in pediatric patients have not been established. The safety and effectiveness of Jakafi for treatment of

steroid-refractory aGVHD has been established for treatment of children 12 years and older. Use of Jakafi in pediatric patients with steroid-refractory aGVHD is supported by evidence from adequate and well-controlled trials of Jakafi in adults [see Clinical Studies (14.3) in Full Prescribing Information] and additional pharmacokinetic and safety data in pediatric patients. The safety and effectiveness of Jakafi for treatment of steroid-refractory aGVHD has not been established in pediatric patients younger than 12 years old. The safety and effectiveness of Jakafi for treatment of cGVHD after failure of one or two lines of systemic therapy has been established for treatment of children 12 years and older. Use of Jakafi in pediatric patients with cGVHD after failure of one or two lines of systemic therapy is supported by evidence from adequate and well-controlled trials of Jakafi in adults and adolescents [see Clinical Studies (14.3, 14.4) in Full Prescribing Information] and additional pharmacokinetic and safety data in pediatric patients. The safety and effectiveness of Jakafi for treatment of cGVHD has not been established in pediatric patients younger than 12 years old. Jakafi was evaluated in a single-arm, dose-escalation study (NCT01164163) in 27 pediatric patients with relapsed or refractory solid tumors (Cohort A) and 20 with leukemias or myeloproliferative neoplasms (Cohort B). The patients had a median age of 14 years (range, 2 to 21 years) and included 18 children (age 2 to < 12 years), and 14 adolescents (age 12 to < 17 years). The dose levels tested were 15, 21, 29, 39, or 50 mg/m2 twice daily in 28-day cycles with up to 6 patients per dose group. Overall, 38 (81%) patients were treated with no more than a single cycle of Jakafi, while 3, 1, 2, and 3 patients received 2, 3, 4, and 5 or more cycles, respectively. A protocol-defined maximal tolerated dose was not observed, but since few patients were treated for multiple cycles, tolerability with continued use was not assessed adequately to establish a recommended Phase 2 dose higher than the recommended dose for adults. The safety profile in children was similar to that seen in adults. Juvenile Animal Toxicity Data Administration of ruxolitinib to juvenile rats resulted in effects on growth and bone measures. When administered starting at postnatal day 7 (the equivalent of a human newborn) at doses of 1.5 to 75 mg/kg/day, evidence of fractures occurred at doses ≥ 30 mg/kg/day, and effects on body weight and other bone measures [e.g., bone mineral content, peripheral quantitative computed tomography, and x-ray analysis] occurred at doses ≥ 5 mg/kg/day. When administered starting at postnatal day 21 (the equivalent of a human 2-3 years of age) at doses of 5 to 60 mg/kg/day, effects on body weight and bone occurred at doses ≥ 15 mg/kg/day, which were considered adverse at 60 mg/kg/day. Males were more severely affected than females in all age groups, and effects were generally more severe when administration was initiated earlier in the postnatal period. These findings were observed at exposures that are at least 27% the clinical exposure at the maximum recommended dose of 25 mg twice daily. Geriatric Use Of the total number of patients with MF in clinical studies with Jakafi, 52% were 65 years and older, while 15% were 75 years and older. No overall differences in safety or effectiveness of Jakafi were observed between these patients and younger patients. Clinical studies of Jakafi in patients with aGVHD did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects. Of the total number of patients with cGVHD treated with Jakafi in clinical trials, 11% were 65 years and older. No overall differences in safety or effectiveness of Jakafi were observed between these patients and younger patients. Renal Impairment Total exposure of ruxolitinib and its active metabolites increased with moderate (CLcr 30 to 59 mL/min) and severe (CLcr 15 to 29 mL/min) renal impairment, and ESRD (CLcr less than 15 mL/min) on dialysis [see Clinical Pharmacology (12.3) in Full Prescribing Information].

Modify Jakafi dosage as recommended [see Dosage and Administration (2.6) in full Prescribing Information].

Hepatic Impairment Exposure of ruxolitinib increased with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment [see Clinical Pharmacology (12.3) in full Prescribing Information].

Reduce Jakafi dosage as recommended in patients with MF or PV with hepatic impairment [see Dosage and Administration (2.6) in full Prescribing Information].

Reduce Jakafi dosage as recommended for patients with Stage 4 liver aGVHD. Monitor blood counts more frequently for toxicity and modify the Jakafi dosage for adverse reactions if they occur for patients with Score 3 liver cGVHD [see Dosage and Administration (2.6) and Clinical Pharmacology (12.3) in full Prescribing Information]. OVERDOSAGE There is no known antidote for overdoses with Jakafi. Single doses up to 200 mg have been given with acceptable acute tolerability. Higher than recommended repeat doses are associated with increased myelosuppression including leukopenia, anemia and thrombocytopenia. Appropriate supportive treatment should be given. Hemodialysis is not expected to enhance the elimination of Jakafi.

Jakafi is a registered trademark of Incyte.

U.S. Patent Nos. 7598257; 8415362; 8722693; 8822481; 8829013; 9079912; 9814722; 10016429 © 2011-2021 Incyte Corporation.

Revised: September 2021 PLR-JAK-00054

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From Our Patients

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We welcome your feedback, article suggestions and photos (high resolution please).

Email to FCSCommunications@FLCancer.com On the cover: Dr. Lucio Gordan with one of his horses at his Gainesville farm.

Photography by Blake Jones

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We have a lot in common with you— The patient is at the heart of everything we do

Scan the QR code below with your smartphone or visit annexushealth.com/fcs to view a personal message from our Co-Founder and CEO Joe Baffone to all of you at Florida Cancer Specialists. We are passionate about helping you help your patients gain access to the care they need—faster and with less financial toxicity.

© Annexus Health, Inc. 2022. All Rights Reserved. AH013 4/22

NATHAN H. WALCKER, CHIEF EXECUTIVE OFFICER

PHYSICIAN LEADERSHIP PRESIDENT & MANAGING PHYSICIAN MICHAEL DIAZ, MD

EXECUTIVE LEADERSHIP CHIEF EXECUTIVE OFFICER NATHAN H. WALCKER CHIEF OPERATING OFFICER JASON COE CHIEF ADMINISTRATIVE OFFICER JOYCE NELSON CHIEF FINANCIAL OFFICER RICH MACCLARY CHIEF INFORMATION OFFICER KEN STURTZ CHIEF LEGAL OFFICER & GENERAL COUNSEL NANCY ARDELL CHIEF PROCUREMENT OFFICER PAUL CHADWICK CHIEF COMPLIANCE OFFICER VALERIE EASTWOOD

IN PARTNERSHIP WITH

PUBLISHED BY

Across our practice, we have embraced this new year of opportunities and challenges at full speed.

Data increasingly drives the actions we take and the decisions we make. In this issue, we shine the spotlight on our recently launched Data Governance Program. It’s a significant initiative that is enhancing our ability to consistently provide exceptional patient care.

You’ll also want to read about our value-based care activities, which continue to rank FCS among the topperforming oncology practices in the country for quality and cost-saving measures.

At all times our work is centered around those who entrust their care to us. There is no greater reward than to hear from our patients that choosing FCS was their best decision ever.

Amy Rodriquez, a breast cancer survivor, tells of her experience with Dr. David Wright and the Tampa Cancer Center team. She describes how every person she encountered welcomed and embraced her like family. The care and support she received enabled her to return to military service, cancer free.

I could not be more proud of the hard work and dedication of our talented and caring physicians and team members. Together we will continue to push FCS to new heights of success and deliver on our promise to our patients by providing world-class cancer care, close to home.

MICHAEL DIAZ, MD, PRESIDENT & MANAGING PHYSICIAN As an oncologist, it is a privilege and an amazing opportunity to help make the world a better place for cancer patients. In my new role as FCS President & Managing Physician, I look forward to helping FCS achieve many more milestones as an innovative leader in communitybased oncology care.

While I am energized by the successes that are ahead of us, certain things will remain constant — above all, our commitment as one team to one mission.

We will continue to lead the way in cutting-edge cancer innovations and discoveries and introduce supportive services that ease stress for patients and families and improve their overall quality of life.

Another constant is our steadfast commitment to improving the access and affordability of cancer care.

No voices are better equipped to make an impact than our dedicated CPAN advocates. They are the patients, survivors, caregivers and clinicians who have experienced cancer firsthand. We are so fortunate for their partnership, and in this issue, you will learn how they are helping eliminate barriers to life-saving community-based cancer care.

Every day, it is our privilege and our passion to serve our patients. Thank you for all you do to help us deliver on our mission.

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LEADERSHIP FEATURE

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LEADERSHIP FEATURE

Following his passion, Chief Medical Officer of Therapeutics and Analytics Dr. Lucio Gordan shifts his focus to data and technology and spending more time with his family, wife Valeria and daughter Julia, on their farm.

Physician Leaders Take on New Roles in the New Year

BY EMMA WITMER, PHOTOS BY BLAKE JONES

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bit of rearranging at the executive level has positioned FCS to achieve new heights of success.

Michael Diaz, MD, FCS Executive Board member, Director of Patient Advocacy and medical oncologist at two FCS locations in St. Petersburg, began the new year as FCS President & Managing Physician. He succeeds Lucio Gordan, MD, who, after serving as FCS’s physician leader for three years, has stepped into a new role that will allow him to continue supporting strategic initiatives in clinical advancements, valuebased care and much more.

“Our journey in creating our national reputation has involved many years of hard work, dedication and commitment, and we are so grateful to Dr. Gordan for his outstanding leadership,” said FCS Chief Executive Officer Nathan H. Walcker. “Dr. Diaz is perfectly positioned to take on this role at this time,” he added, citing his long-term commitment to patients and his career focus on ensuring access and affordability to cancer care.

Diaz has been influential in both state and national policy, often organizing grassroots campaigns to block legislation that could pose harm to cancer patients. As a member of the Florida Medicaid Pharmaceutical and Therapeutics Committee, Diaz has worked to revamp the practices of pharmacy benefit managers and helped develop alternative oncology payment models with the American Society of Clinical Oncology, Community Oncology Alliance and the Centers for Medicare and Medicaid Services Innovation.

Diaz says, “Patients need and deserve to get excellent quality, and there is no reason that should be sacrificed for monetary reasons. You can balance both, and that’s what I have been striving to do.”

As FCS President & Managing Physician, Diaz is committed to working on behalf of patients and healthcare

Michael Diaz, MD President & Managing Physician

Lucio Gordan, MD Chief Medical Officer of Therapeutics and Analytics

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providers and continuing his focus on quality, research, advocacy and innovation.

His priorities involve networking with other medical disciplines to centralize patient care, addressing health disparities with pharmaceutical companies and investing in more personalized treatment through the continued advancement of next-generation sequencing.

“It’s an amazing honor and privilege to take on the role of president,” Diaz said. “My colleagues have expressed their confidence in what I’ve done in the past, and they are trusting me to continue to do that in the future. I take that very seriously.

I am going to continue to do everything I can to earn that confidence and respect.”

For Gordan, his new role as Chief Medical Officer of Therapeutics and Analytics is a thrilling opportunity to dive more deeply into a topic that has been a lifelong passion and can prove revolutionary in the quality of care offered to FCS patients.

Data and informatics have always fascinated Gordan. As a child growing up in Brazil, Gordan taught himself to do coding and developed computer software beginning at age 11. He was insatiably

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curious about how data could be used to help others and to improve understanding of the challenges in the world around him.

As a practicing medical oncologist with FCS’s Gainesville Cancer Center, Gordan understands the importance of data to improve patient care.

Data allows clinicians to provide personalized treatment based on key factors in the patient’s demographic information, medical history and genomics. A data-driven approach expedites the process of finding the right medications and leads to improvement in drug adherence, dose density and dose intensity. Well-organized data is also a key factor in getting qualified patients into potentially life-saving clinical trials.

FCS is sitting on a treasure trove of data.

It’s a massive undertaking to sort through all of it, but with the help of the Data Governance Committee and other FCS teams, Gordan is ready for the challenge.

“As it was during my time as President & Managing Physician, my goal as Chief Medical Officer of Therapeutics and Analytics is to move the needle a bit faster to impact our full patient population,” he said.

LEADERSHIP FEATURE

A DIFFERENT KIND OF SADDLE AND REINS PROVIDE PASTIME AND PASSION Gordan reserves weekend mornings for exercising his horses. He owns a 30-acre farm near Gainesville, where he keeps a few mini-donkeys and a dozen horses. His favorite horse, a Hanoverian-Tennessee Walker named Redford, is always up for a ride.

“They are my psychiatrists on staff,” Gordan said of his horses, with whom he spends regular

non-office hours. “When I was president, the executives knew not to call me between 8 a.m. and noon on Saturday and Sunday. If they did, they knew not to expect an answer.”

Refreshed by pastoral pursuits, Gordan returns to data, whose utility he understands and appreciates.

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PATIENT SPOTLIGHT

Conquering Breast Cancer Warrior spirit helped Amy Rodriguez stay positive

BY HANNAH BURKE

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hose who know Amy Rodriguez will tell you she’s more than a fighter.

She’s a warrior.

Her 17 years of service as a U.S. Army National Guard Staff Sergeant have earned Rodriguez more than a dozen honors, including the Joint Service Commendation Medal, the Army Achievement Medal and the Army Commendation Medal.

Still, Rodriguez’s recent triumph over breast cancer is her sweetest victory yet.

After a long and arduous year-and-a-half of treatment, Rodriguez is grateful for the chance to keep serving her community and country and to continue raising her son and watching him grow up.

“I have FCS to thank for that,” Rodriguez said.

The Tampa native received her breast cancer diagnosis in 2020, after a concerning self-exam.

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“I had an aunt who had breast cancer years prior, so I was very adamant about regularly checking myself,” she said. “When I found a lump, I didn’t think much of it, but I mentioned it to my mother-in-law.

She insisted I get it checked out.”

Two weeks later, Dr. Abigail Beard at USF Health confirmed Rodriguez’s worst fear and referred her to Dr. David D. Wright at FCS. Seeing Wright for treatment, Rodriguez said, was “the best decision ever, hands down. I felt very comfortable with him and with his patient care staff. The way they welcomed me made me feel like I was a part of their family.”

Wright, who sees patients at FCS’s Brandon Cancer Center, New Tampa and the Tampa Cancer Center, attended medical school at the University of South Florida’s Moffitt Cancer Center. It was during his first year of school that Wright’s mother received her own cancer diagnosis.

“My mother’s oncologist treated her like she was family,” Wright told FCS in a video testimony. “He spent time with her like she was the only person that mattered to him, and I’m sure he had about 20 other patients waiting. Her outcome was very good; he became a friend of the family and she’s still with us. I realized the important thing, for me, was the personal touch. Now, I have patients that have become part of my life.”

Rodriguez remembers how, at her very first visit with Wright, he called her by her first name, as if they were already friends.

Wright took the time to get to know her, she said, and ensured that she was comfortable from the very beginning.

“When I walked in for treatment every day after, I was always greeted with a smile,” Rodriguez said. “From the front door staff to the individuals who put in my IV, everyone was amazing.”

PATIENT SPOTLIGHT

Traveling the world, U.S. Army National Guard Staff Sergeant Amy Rodriguez has built a lifetime of unforgettable experiences.

“I 100% believe that Florida Cancer Specialists helped me beat cancer…Thank you, care team. Thank you for loving me through both your actions and words, and thank you for making this experience something I will never forget.”

One day, Rodriguez took it upon herself, while undergoing chemotherapy, to shave her head. She continued filling in her eyebrows and doing her makeup, but she still grappled with the insecurities that follow such a drastic change. What if she was now unrecognizable?

Turns out, at Rodriguez’s next appointment, an FCS staff member would supply her with a much-needed boost of confidence.

“I can’t recall her name, but I remember coming in and seeing her look at me with just the widest smile,” Rodriguez said. “Her eyes were just gleaming, and she told me, ‘You are so beautiful.’ She remembered me.”

After months of treatment, a double mastectomy and reconstructive surgery, Rodriguez said she’s “feeling great — as though I’m back to myself.” She finished her last round of treatment in May 2021, is forging ahead with her military career, and reports that, despite everything, she continues to pass her physical fitness tests.

Rodriguez is, to many, a hero.

Last November, she was officially recognized as such by the Tampa Bay Buccaneers at Raymond James Stadium.

Prior to the Bucs’ home game against the Chicago Bears, Rodriguez, the “Hero of the Game,” received the traditional honor of “rallying the Krewe” by ringing the bell of the team’s pirate ship. She beamed, danced and beckoned the crowd to match her enthusiasm.

For Rodriguez, that fervor isn’t reserved just for game days, but for every day she can continue living, serving others and loving her family.

“I 100% believe that Florida Cancer Specialists helped me beat cancer,” Rodriguez said. “Thank you, care team.

Thank you for loving me through both your actions and words, and thank you for making this experience something I will never forget.”

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Data Governance Company-wide initiative will provide standards for collection and storage

BY HANNAH BURKE

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ast year, Florida Cancer Specialists enthusiastically launched its Data Governance Program, an initiative designed to institute policies, processes and standards for how data is collected, organized, stored and used throughout the organization.

The FCS Data Governance Committee was established to oversee the program’s implementation and monitor its progress. FCS Chief Executive Officer Nathan H. Walcker serves as executive sponsor of the committee and Vice President of Informatics Trevor Heritage, PhD has taken on the role of committee chair.

It was important to FCS that the committee include representatives from the organization’s teams and departments. Data plays a role in every sector of FCS operations, so this initiative impacts everyone.

For instance, FCS data may also correlate with how clinical interventions and observations are documented, or the way in which patient information is attained at intake and later stored, analyzed and secured. Data can relate to billing and claims, or even include the acronyms used by FCS to refer to its clinic locations.

“Like other organizations of our size, complexity and structure, there are many possible ways in which the cross-system exchange of data and information could be inconsistent,” Heritage said. “So, it is vital that we have a plan in place to strengthen the management of our data and ensure that it is reliable, secure and being properly used. By doing this, we can more efficiently and deliberately use our organization’s data to continue providing world-class cancer care for our patients.”

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DATA GOVERNANCE

For more than three decades, FCS has been dedicated to its mission of providing communities across Florida with premier cancer care and treatment. As the organization continues to grow and evolve, FCS believes it is imperative that its data infrastructure, practices and protocols follow suit.

Walcker said employees will be kept apprised of developments in its new “data driven culture” via updates from the Data Governance Committee members, who will serve as the program’s central decision makers. They plan to furnish reports on process improvement milestones and contemporary examples of the program’s impact across FCS.

In addition to the Data Governance Committee, subject matter users and experts who frequently use and interact with data comprise the FCS Data Stewards Council.

They will work to break down data silos by identifying the best ways for individual departments to gather, manage and implement data, as well as how to effectively receive and apply data created by other FCS branches.

While the framework for data governance has been set, it will take time, patience and cooperation from all team members to realize the program’s full vision. The Data Governance Committee has already identified both short- and long-term goals, and, Walcker said, “Its progress will be frequently monitored and communicated.”

“By doing this, we can more efficiently and deliberately use our organization’s data to continue providing world-class cancer care for our patients.”

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ADVOCACY SPOTLIGHT

Strategic Partnership FCS and COA advance interests of patients

BY EMMA WITMER

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uilding a better system for cancer care is a job too big for one organization, no matter how dedicated its staff may be.

Given that reality, FCS partners with organizations such as the Community Oncology Alliance (COA).

Rose Gerber is Director of Patient Advocacy and Education for COA’s Patient Advocacy Network (CPAN) that works closely with FCS and other practices around the country to spearhead policymaking, innovation and reform of the cancer care system.

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“I just love the FCS chapter,” Gerber said. “They keep me inspired. A lot of what I do is educating and mentoring others. I try my best to keep leaders interested, and when I have leaders like Beth Wittmer, Dr. Mike Diaz and Dr. Lucio Gordan, who are high-ranking within the practice and truly support advocacy, I know we can accomplish great things.”

FCS launched its CPAN chapter in 2014, under the joint leadership of then Director of Care Management Don Champlain, RN, MHA, and current Director of Care Management Beth

Wittmer, RN, OCN. The two served as cochairs of the chapter for three years until, sadly, Champlain lost his battle with cancer.

Over the last eight years, Wittmer and Gerber have worked side by side to educate clinicians, patients, survivors and their families on the complex system of cancer care and empower them to act.

As the CPAN chapter leader for FCS, Wittmer is in constant contact with liaisons throughout the FCS network to garner support. She organizes quarterly physician-led speaking events with patients and families to provide education and identify what

ADVOCACY SPOTLIGHT

“Our goal with CPAN is to make people more aware of what they can do by standing up and advocating for cancer care and the difference that it truly makes in the community setting.”

legislation is coming up that could be helpful or detrimental to their care. Even with the challenges posed by COVID-19 restrictions, Wittmer has persevered with virtual events. ​​“Our goal with CPAN is to make people more aware of what they can do by standing up and advocating for cancer care and the difference that it truly makes in the community setting,” Wittmer said. “We are always looking for ways to bring more awareness to the importance of this chapter and the need for more patients, families and FCS team members to get involved.

FCS doctors and nurses have added powerful voices to numerous state and national CPAN events by identifying patients willing to share their cancer stories through the “I AM Community Oncology” campaign. In addition, FCS has invited Sen. Rick Scott and Sen. Marco Rubio to experience FCS facilities through the “Sit in My Chair” event. Prior to the pandemic, live visits were hosted in FCS clinics throughout the state.

Time and again, CPAN advocates from FCS have espoused the importance of affordable and easily accessible care and the value of clinical trials, and they regularly speak on CPAN patient advisory boards at statewide events and on Capitol Hill.

One issue that the chapter has worked to address is the impact of pharmacy benefit managers on access to medication.

FCS and CPAN have also worked in tandem to block legislation like the Trump

Top: Dr. Lucio Gordan and Alachua County representatives participate in Sit in My Chair, an opportunity for local representatives to gain an understanding of the community oncology experience from the patient's perspective.

Bottom: Members of the CPAN committee join together at the last in-person COA Conference in 2019.

administration’s Most Favored Nation proposal, which would have barred at least 20 percent of cancer patients on Medicare from access to treatment.

“We want to de-complicate these issues so that patients and their families have a good understanding of what their rights are and so that their voices can be heard at the legislative level,” Wittmer said.

“The work we do with CPAN is so important,” added FCS President & Managing Physician Michael Diaz, MD. “The better we initiate and educate our

patients, the better they can advocate for themselves. It helps them understand how and where they can turn for support, and it helps them understand that they are not alone in this process. If we can work together, we can help them navigate through what can be one of the most difficult times in anyone’s life.”

Email the FCS CPAN group for more information or to learn how you can get involved at CPAN@FLCancer.com.

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VALUE-BASED CARE PROGRAM

FCS Retains Top Ranking Among OCM Participants

BY HANNAH BURKE

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n 2016, the Center for Medicare & Medicaid Innovation (CMMI) developed the Oncology Care Model (OCM), a national payment program that provides high-caliber, efficiently managed cancer care at a lower price to Medicare beneficiaries.

FCS has been enrolled in the program since its inception, and according to CMMI’s most recent OCM reconciliation data, has once again been ranked at the top among the 126 participating oncology practices across the country.

With its community-based and personalized practices, state-of-the-art clinical trial offerings and dedication to offering patients individualized, worldclass cancer care, FCS’s ranking comes as no surprise to FCS Chief Executive Officer Nathan H. Walcker.

“Our value-based practice initiatives at FCS are programmatic, intentional and thoughtfully designed to be organized squarely around the patient, yielding consistent results that outpace industry benchmarks and make good on our commitment to prioritize patient outcomes and quality,” Walcker said.

“I could not be prouder of our entire team and their steadfast commitment to delivering value-based oncology care in communities across Florida.”

FCS provides care for more than 22,000 OCM beneficiaries annually and has recorded more than

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VALUE-BASED CARE PROGRAM

FCS has recorded over

$140M

in Medicare savings since 2016

21%

FCS had fewer cases of emergency visits, preventing admission

$140 million in Medicare savings since 2016. In the last six-month performance period of 2021, FCS saved Medicare $31.7 million.

Participation in OCM, said FCS Director of Value-Based Care TR Strickland, has allowed FCS to make “substantial strides and investments in our strategic focus on value-based programs.” FCS has succeeded in partnering with Accountable Care Organizations (ACOs), Managed Service Organizations (MSOs) and commercial/Medicare Advantage payers “across our Florida markets to continue reducing care costs and prioritizing patient satisfaction.”

FCS embodies all the values engaged by the spirit and the goals of the OCM demonstration initiative, which aims to not only cut costs, but more importantly, incentivize and promote enhanced systems and processes that promote “better care, smarter spending and healthier people,” according to the CMMI website. This is, in essence, the overriding goal of the triple aim – improving care experience, population health and reducing costs – for all of healthcare delivery.

FCS consistently reports on upwards of 50 quality-of-care metrics per performance period to help measure OCM effectiveness. Of those 50, FCS received exceptional scores in the areas of pain assessment, emergency room visits/inpatient hospital stays, prevention/screenings, appropriate utilization of hospice, patient-reported experience and patient satisfaction.

CMMI’s most recent report also shows that FCS hospital admissions were 8% lower than

8%

FCS had fewer hospital admissions than other practices

those of other OCM-enrolled practices and, in that same period, FCS had 21% fewer cases of emergency room visits, preventing admission.

FCS Chief Medical Officer for Therapeutics & Analytics Lucio Gordan, MD attributes the organization’s success with OCM and other value-based programs to prioritizing a “wellbuilt” infrastructure.

“At FCS, our guiding principle is to put the patient first in everything we do; we are laser-focused on providing world-class cancer care while reducing the overall cost of that care for our patients,” Gordan said. “In the long run, quality care doesn’t increase costs, as quality delivered at the right time in the most appropriate venue often decreases overall costs and prevents adverse events.”

FCS will continue to leverage OCM value principles and infrastructure and expand the scope of its own value-based care programs to support the long-term objective of consistent, high-quality treatment. To do so, we continuously refine our patient education libraries, supply expanded resources for after-hours symptom management, and ancillary services like nutritional health and behavioral health to improve access and reduce care costs through the use of generic and biosimilar drugs when possible.

“Simply put, exceptional, value-based cancer care centered around our patients, and within their own communities and support systems, is the core of our organizational mission and a fixed focus we will never waver from,” Walcker said.

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2021 OpportUNITY Annual Operations Meeting Recap

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or the first time in nearly two years, our operations team gathered in person at Raymond James Stadium in Tampa for their annual meeting. The November meeting’s theme, “OpportUNITY,” reinforced the unification of our teams across Florida in our efforts to provide patient-centered care.

Throughout the day, the group of over 250 office and nurse managers heard from FCS leaders, gaining insight and perspective of past accomplishments and a glimpse at the road ahead.

Undoubtedly, the past several months have been challenging, especially for our operations teams, but the message echoed throughout the day was one of pride and gratitude. The perseverance and dedication of this team is undeniably what has enabled our patients to continue trusting in our care, our physicians to continue practicing medicine and our research to continue fueling the majority of the new oncology treatments in the country.

The day was filled with moments of appreciation, recognition, reflection and preparation. Chief Operating Officer Jason Coe kicked off the meeting, while Immediate Past President and Managing Physician Dr. Lucio Gordan thanked the group for their hard work and encouraged them to take care of themselves and their teams. Chief Executive Officer Nathan H. Walcker recapped FCS’s accomplishments and shared strategies for the new year, which include engaging every FCS team member as new technologies and processes are put in place to improve our delivery of cancer care. Dr. Michael Diaz, President and Managing Physician, spoke of the future, complimenting the teams’ efforts and sharing his confidence in achieving the

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goals set forth by the executive board and the leadership team. They also heard from Chief Administrative Officer Joyce Nelson, who shared how FCS continues to be an employer of choice, highlighting the numerous benefits available to all FCS employees.

With this in mind, the focus shifted inward to the individuals in the room and those they lead. Inspired by thoughtprovoking presentations from Senior Vice President of Organizational Effectiveness and Learning Marilyn Morales and Director of Clinical Education Delia Edson, they took a deep look at how every individual in FCS impacts patient experience and explored the necessary steps to prioritizing how we take care of our own team members. Statistically, when individuals are engaged and feel valued, it is projected through their work, and our practices are no exception. In our case especially, this cascades to the patients in the care we provide.

With Thanksgiving right around the corner, the final team-building activity of the day involved filling baskets with the necessities for a complete holiday dinner.

Teams competed in minute-to-win-it challenges earning a trip to the “store” to gather food supplies. When all was said and done, the group had assembled more than 20 overflowing baskets for some of our own FCS patients.

At the end of the day, the goal was for the group to have a clear understanding of where the organization is headed and feel empowered in leading and uplifting their own teams to deliver better patient-centered care across the organization. Equally as important, all left with the understanding that their executive leadership team and physicians are aligned and dedicated to supporting them in their roles as we head into the new year. One team. One mission.

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FCS OPERATIONS TEAM MEETING

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1. OpportUNITY 2021 brought the FCS Operations Team together in person for the first time in nearly two years. 2. Participants raced to the "store" to fill holiday dinner baskets for patients. 3. Teams competed in minute-to-win-it challenges. 4. Team members were energized after spending a day focusing on building better teams and delivering better patient care.

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5. Team members stocked up on all the necessities for patients to create the ultimate holiday meal. 6. At times, carrying the supplies back to the tables was the most challenging task. 7. It took real teamwork to solve the puzzles. 8. Each challenge required full team participation to meet the time restriction. 9. Teams arrange and decorate baskets filled to the brim with all the necessities for a holiday meal. 10. Chief Operating Officer Jason Coe kicks off OpportUNITY 2021.

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FCS OPERATIONS TEAM MEETING

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11. Hearing from executive leaders on future FCS strategies was insightful and entertaining. 12. Senior Vice President of Organizational Effectiveness & Learning Marilyn Morales led a breakthrough discussion on evolving patient care delivery. 13. Chief Executive Officer Nathan H. Walcker sets the stage for the strategies coming in 2022. 14. Director of Clinical Education Delia Edson spoke to the team about the importance of continuing clinical education and leadership opportunities. 15. Throughout the day, team members were connecting and laughing, and working together toward a better future. 16. After spending nearly two years apart, it felt good to bring everyone together.

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PEOPLE & PLACES

NEWEST DRUG DEVELOPMENT UNIT OPENS IN LAKE NONA In collaboration with Sarah Cannon and the University of Central Florida College of Medicine (UCF), FCS has opened its newest drug development unit (DDU).

Located in the Sarah Cannon UCF Lake Nona Cancer Center, the new 10,000-square-foot DDU is part of a new treatment facility which combines medical oncology services and Phase 1 clinical trial options for cancer patients in one convenient location.

Led by Cesar Augusto Perez, MD, a recognized expert in Phase 1 oncology research, the DDU focuses exclusively on oncology clinical trials at the earliest phases of research and was designed to meet the specialized needs of patients seeking advanced cancer treatment options.

STATE-OF-THE-ART CANCER CENTER OPENS IN NORTH PORT

A ribbon-cutting celebrated the opening of the new North Port Cancer Center located at 1390 Grand Venture Drive. In nearly 20,000 square feet of space with 16 exam rooms, 45 chemotherapy infusion chairs and PET/CT scan technology, along with laboratory, oral oncolytic specialty pharmacy and care management services, patients receive the most advanced and personalized treatments and services.

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NEW TRINITY CANCER CENTER EXPANDS SERVICES IN PASCO COUNTY

The FCS Trinity Cancer Center is now open at 9320 State Road 54. The 37,000-square-foot facility has replaced the two prior FCS locations in Trinity.

It includes 27 exam rooms and 54 chairs for chemotherapy and other infusion therapies, as well as radiation oncology and next-generation PET/ CT imaging technology, laboratory, oral oncolytic specialty pharmacy and care management services for patients participating in value-based care. Even the Tampa Bay Lightning's Thunderbug came out to see the new space.

NEW CANCER CENTER OPENS IN MANATEE COUNTY

A ribbon-cutting marked the opening of the new state-of-the-art FCS Bradenton Cancer Center located at 3630 Manatee Ave. W., which replaces the two prior FCS locations in Bradenton. With greatly expanded treatment space, the clinic includes 18 exam rooms, 50 infusion chairs and on-site imaging, laboratory and pharmacy services. Care management and access to clinical trial research opportunities are also available to patients.

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PEOPLE & PLACES

LEADERSHIP APPOINTMENTS & PROMOTIONS Chris Chadwick Vice President Service Delivery & Infrastructure Chris oversees the management, development, delivery and maintenance of the FCS IT infrastructure and service delivery functions, and drives the planning and deployment of strategic initiatives to enhance all end-to-end IT solutions. An accomplished leader in enterprise support and infrastructure management, Chris has extensive experience in global team building, client management and data-driven process engineering with a focus on maximizing efficiency, service delivery and client satisfaction.

Josh Eaves Senior Vice President Corporate Development A seasoned business development and sales professional with nearly 20 years of experience, Josh is responsible for FCS’s new business development initiatives, including strategic partnerships, service line innovation and expansion. He brings a wealth of expertise developing strategies designed to improve access to the scope of oncology services and resources.

Inga Gonzalez Senior Vice President Practice Operations Inga oversees clinic locations covering FCS’s presence in Central and Northeast Florida, leading the implementation of strategic imperatives to drive patient satisfaction, physician and team member engagement, and improve efficiencies and effectiveness within the clinical setting. She has a key role in the development and redesign of new sites of care to support the growth of the practice and also works to strengthen and expand relationships with healthcare systems, referring physicians, vendors and other market-based partners. Inga joined the FCS operations team in 2009 and was named FCS Vice President of Operations for Central Florida in 2017.

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Ken Sturtz Chief Information Officer As Chief Information Officer, Ken Sturtz, MBA, MHA oversees all information technology operations and drives digital innovation company-wide. He joined FCS in March 2022, bringing more than 15 years of healthcare IT executive leadership experience across multiple care settings in military, academic, private and non-profit healthcare sectors. Prior to joining FCS, he served as Chief Information Officer for Brooks Rehabilitation in Jacksonville, Florida, where he led enterprise infrastructure, application, security, analytics and end-user support services encompassing multiple locations of inpatient and outpatient senior care and living facilities. During his 20-plus-year career with the U.S. Army, he held a variety of increasingly responsible positions and served within Chief Information and Chief Technology Officer roles, providing support to numerous hospitals and health care facilities in the U.S. and overseas.

Amy Pacey, MBA, SPHR Senior Vice President People & Culture A Senior Human Resource Executive with over 30 years of experience, Amy oversees strategic HR initiatives, supporting FCS in becoming a choice employer by enhancing talent management and attraction practices, improving efficiency and effectiveness of HR and implementing workforce planning, engagement and diversity initiatives. She also serves as FCS’s Diversity Officer.

Marilyn Morales, EdS, MS, MBA, LBBP, CPT Senior Vice President Organizational Effectiveness & Learning Marilyn drives learning, performance improvement and engagement strategies to foster confidence, success and continuous learning for team members at all levels. Collaborating with key stakeholders across the organization, she oversees employee safety and well-being, enculturation of the patient experience and management of key external relationships with clinical programs and educational institutes.

Marilyn joined FCS in 2018 as Vice President Organizational Effectiveness & Learning, also serving as FCS’s Learning Officer.

Jeffrey Rubin Senior Vice President Operations Jeff joined FCS in 2003 and was named Vice President of Practice Operations in 2015, after serving as Senior Regional Director. He oversees clinical locations from Tallahassee to Naples, and leads implementation of strategic imperatives to drive patient satisfaction, physician and team member engagement and improve efficiencies and effectiveness within the clinical setting. Jeff also plays a key role in development and redesign of new care sites, supporting practice growth, and works to strengthen and expand relationships with healthcare systems, referring physicians, vendors and other marketbased partners. He brings extensive practice management experience and a clinical perspective to his senior leadership role.

FOUNDATION UPDATE

FCS Foundation News & Events

Our Mission: Providing non-medical financial assistance to adults undergoing cancer treatment in Florida to allow them to focus on fighting cancer.

In 2021, the FCS Foundation awarded more than $1.4 million in grants.

“Thank you so much. This is great news! Our home was destroyed by Hurricane Irma, and we have been accepted to receive a replacement home. You are proof that not all angels have wings. God bless you for all you have done for us.”

— Gabriela and Sam Jauregui with their children, Kristin and Sam Jr.

Lyrics for Life On March 5, Rich and Carissa Blaser partnered with the band Sister Hazel and special guest artists Ezra Ray Hart for a very special night in Gainesville to support Lyrics for Life’s Camp Hazelnut, Stop Children's Cancer and Florida Cancer Specialists Foundation.

Farm to Table 2022 In late January, guests joined the FCS Foundation for an evening in Ocala, Florida. The farm-to-table experience event included local fare, entertainment, auctions and more. All proceeds provided non-medical financial assistance to cancer patients.

FCSF.org

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Phone: 941-677-7181

/FLCancerFoundation

Wine Women & Shoes May 21, 2022, JW Marriott, Orlando

/florida-cancer-specialists-foundation

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PATIENT FEEDBACK

From Our Patients I have been your patient for over five months. I want to thank you for the wonderful care you are giving me for my ferritin issues.

Adewale A. Fawole, MD You are a great physician, and it shows — not only by the excellent care you have given me but also your kind demeanor and your patience with me as we discuss my treatment.

Your staff is outstanding. I know I do not have all of the names, but please know that they ALL do an excellent job and truly show that they want to provide the best care for your patients. The check-in and check-out desks (Kim, Nabeela, Keri, Me’Shelle and Hannah), the lab (Ben, Carolyn, Tiffany and Chelsea), and the lab technicians that analyze the blood samples are all excellent.

The nurses (Tamara, Jessica and Connie) in the treatment area have a very stressful job treating the many cancer patients. They always have a positive and friendly attitude toward every patient. I actually enjoy my visits just because of the way I am treated with such great care.

Also, Florida Cancer Specialists has built a beautiful facility. It certainly helps patients, who are somewhat depressed having to go through rigorous treatments, to come to such a wonderful place with beautiful artwork and great caregivers.

I appreciate everything you are doing for me.

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FCS Magazine

HEALTHGRADES REVIEW: 5 STARS

Perfect. Dr. Lunin has the best staff I have ever dealt with. Prompt, professional and caring. They are perfect representatives of the best doctor I have had the pleasure of knowing in my 40 years as a patient. I have had dealings with great institutions like Columbia University Scott D. Lunin, MD Medical Center, The Cleveland Clinic and Sloan Kettering. Several of my surgeons are world-famous.

In my book, if I had to choose one doctor to treat a loved one, Scott Lunin would be my choice.

HEALTHGRADES REVIEW: 5 STARS

I highly recommend Dr. Suleiman and his staff. You cannot describe the caring feelings you get from Dr. Suleiman. He is a one-in-a-million physician that never gives up, treats the whole person and is extremely knowledgeable, kind and caring. He is the perfect physician.

Yaman Suleiman, MD

HEALTHGRADES REVIEW: 5 STARS

Dr. Velez is the best doctor I’ve ever seen, and we see a lot of doctors. He’s professional, extremely knowledgeable and thoughtful. The medical system is lucky to have him! His staff is amazing also. All-around great facility and care.

Michel Velez, MD

GOOGLE REVIEW: 5 STARS

I love Dr. Tang. I was diagnosed with stage 4 breast cancer in July 2021. I’m 34, and before this diagnosis, I was always healthy — not even a cold could stop me. Months in, my scans are better and tumors throughout my body are disappearing.

Dr. Tang is saving my life, and I couldn’t Thomas H. Tang, MD have chosen a better doctor. Plus, he always sticks by me when I’m not always the best patient. I’ve had a hard time with doctors telling me what to do constantly, but I’m getting better as time moves along. I thank you, Dr. Tang and everyone at Florida Cancer Specialists, for your patience with me.

You’re all amazing to me, and I’m forever grateful.

GOOGLE REVIEW: 5 STARS

GOOGLE REVIEW: 5 STARS

Dr. Gail Wright took excellent care of my husband for many years and due to her caring and expertise in oncology — he has been in remission for around 20 years. I'm so grateful to have her as his doctor.

Dr. Sai’s office is fantastic. The staff is attentive, hardworking, knowledgeable and highly qualified.

Dr. Sai is very caring and knows her patients’ needs. Flagler County is lucky to have the services of this office, and the patients who Padmaja Sai, MD visit this office are very fortunate to benefit from the efforts of all staff. I have spoken to and know many people who are past patients of Dr. Sai and have been told in detail about what this office has accomplished for so many. Thank you Dr. Sai!

Gail Lynn Shaw Wright, MD

GOOGLE REVIEW: 5 STARS

Dr. Bustamante has been, honestly, the absolute best. From my very first initial appointment where we met, she made me feel so comfortable.

She made me feel like I would be in the best hands with the best care ever! Fifteen chemotherapies later, Liliana Bustamante, MD I can honestly say that I admire Dr. Bustamante so much. I love seeing her, speaking with her, sharing things with her. Having her as my doctor has been life-changing. She truly is passionate about what she does and doesn’t treat you like just another patient. Truly blessed to have had the best doctors and nurses working at my side.

GOOGLE REVIEW: 5 STARS

I am so blessed to have connected with Florida Cancer Specialists, especially Dr. Jay Wang, who I trust completely, and the nurses and staff who are so welcoming, skillful, knowledgeable and compassionate. I had my first Jay Wang, MD treatment for triple negative breast cancer recently and it was as pleasant as possible with such caring people. I know I have a journey ahead of me, but with the support of Dr. Jay Wang and staff, I will do well with all the support.

GOOGLE REVIEW: 5 STARS

Dr. Patel is an amazing physician! I feel so fortunate that I was referred to her for my treatment. She takes time to listen and answer all questions.

Her compassion and concern for her patient’s physical and emotional well-being is unparalleled. Thank you Dr. Patel for saving my life!

GOOGLE REVIEW: 5 STARS Rina Patel, MD

GOOGLE REVIEW: 5 STARS

Dr. Heldreth and all of the staff at FCS saved my life! I was diagnosed with Stage 4 lung cancer in 2015, and I have now been treatment free for 2.5 years! Through their diligent testing and research, I never “fell through the cracks.” I was Douglas D. Heldreth, MD always the first priority. To say “thank you” is such an understatement!

Ayman Barakat is the best. I've been going to him for three years now and will continue to do so. He and his staff were always kind and most importantly, made me feel comfortable. Whatever concerns I had, he addressed them. He is Ayman Barakat, MD honest, kind and, in my opinion, the best in what he does. I would not go anywhere else.

Have something to add?

You can submit your feedback by emailing us at FCSCommunications@FLCancer.com.

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