PIPELINE DRUG LIST continued

(in combination with cytarabine &/or anthracycline induction & consolidation, and monotherapy following consolidation)

RSV pre-fusion protein vaccine (PF-06928316)

(maternal administration for RSV prevention from birth to 6 months of age)

Actemra) carcinoma; Melanoma (BRAF-mutant); NSCLC; SCLC; Soft tissue sarcoma; Urothelial infections; Amebiasis; Bacterial infections caused by certain microorganisms ranibizumab (biosimilar to Genentech’s Lucentis)

Stada Arzneimittel/ Xbrane Diabetic retinopathy; DME; Myopic choroidal neovascularization; Macular edema following RVO; Wet AMD

(dual-action tablet)

Prostate cancer (BRCA+, metastatic, castrationresistant, in combination with prednisone) fruquintinib Hutchmed/Eli Lilly CRC (refractory, metastatic) aflibercept (biosimilar to Regeneron’s Eylea) bevacizumab (biosimilar to Genentech’s Avastin) bevacizumab (biosimilar to Genentech’s Avastin) bevacizumab (biosimilar to Genentech’s Avastin) cipaglucosidase alfa

Biocon/Janssen DME; Diabetic retinopathy; Macular edema following RVO; Wet AMD

Bio-Thera Solutions/ Sandoz Brain cancer; Cervical cancer; CRC; NSCLC; Ovarian cancer; RCC

Centus Brain cancer; Cervical cancer; CRC; NSCLC; Ovarian cancer; RCC

Samsung Bioepis/ Organon Brain cancer; Cervical cancer; CRC; NSCLC; Ovarian cancer; RCC disease (in combination with oral miglustat) debamestrocel Brainstorm ALS Intrathecal filgrastim (biosimilar to Amgen’s Neupogen) pegfilgrastim (biosimilar to Amgen’s Neulasta) pegfilgrastim (biosimilar to Amgen’s Neulasta) Lupin tislelizumab Beigene/Novartis Esophageal squamous cell carcinoma (unresectable or metastatic, 2nd-line) tixagevimab/cilgavimab (EvusheldTM)

NAME

MANUFACTURER CLINICAL USE DOSAGE FORM DEVELOPMENT STATUS FDA DECISION

Nasopharyngeal cancer (advanced recurrent/ metastatic, 1st-line with gemcitabine & cisplatin, subsequent monotherapy)

IV Submitted − BLA; Breakthrough Therapy; Orphan Drug

Pending

(ages 1 to < 4 months of age) brexpiprazole (Rexulti®) Otsuka Alzheimer’s disease (neuropsychiatric symptoms) upadacitinib (Rinvoq®) Abbvie CD (moderate to severe) atezolizumab (Tecentriq®) Genentech Sarcoma (alveolar soft part) letermovir (Prevymis™) Merck CMV prophylaxis (high risk adult kidney transplant recipients [D+/R-]) odevixibat (Bylvay®) Albireo Alagille syndromeassociated cholestatic pruritus

− sNDA; Orphan Drug

Oral Submitted − sNDA; Breakthrough Therapy; Orphan Drug obeticholic acid (Ocaliva®) Intercept NASH-related precirrhotic liver fibrosis Oral Submitted − sNDA; seeking Accelerated Approval; Breakthrough Therapy

Regeneron Diabetic retinopathy; Wet AMD; DME (all with extended dose interval)

06/22/2023 brentuximab vedotin (Adcetris®)

Seagen

Hodgkin’s lymphoma (advanced, 1st-line)

Intravitreal Submitted − sBLA; Priority Review 06/27/2023

IV Submitted − sBLA; Breakthrough Therapy; Fast Track; Orphan Drug