Metastatic Breast Cancer 1, 70 | Newly Approved Oncology Drugs
1, 19, 33, 50
| Refractory Hairy Cell Leukemia
VOLUME 6, ISSUE 22
28, 34, 35
DECEMBER 10, 2015
Editor-in-Chief, James O. Armitage, MD | ASCOPost.com
FDA Update
November Yields Record Number of FDA Approvals for New Oncology Drugs and Drug Indications By Jo Cavallo
By Chandrakanth Are, MBBS, MBA, FRCS, FACS
I
n 2014, the U.S. Food and Drug Administration (FDA) approved 9 new drugs and biologics in the treatment of cancer and added 10 notable new indications or formulations to existing drug labels, marking a year of significant progress in improving the quality of cancer care in the United States. So far this year, the FDA’s Center for Drug Evaluation and Research has already surpassed that number, with 13 new drug approvals—6 in November alone—plus 13 new drug indications or formulations and 1 expanded indication for lenalidomide (Revlimid) in combination with dexamethasone for newly diagnosed patients with multiple myeloma.1 (See related reports from JADPRO Live at APSHO [page 19], for FDA Update [pages 21, 33, and 50], and for In the Clinic [pages 40, 120, 123, and 124].)
Among the list of anticancer therapies approved this year are a number of FDA-approval firsts, including ixazomib (Ninlaro), the first approved oral proteasome inhibitor in the treatment of multiple myeloma; panobinostat (Farydak), the Richard Pazdur, MD first-ever histone deacetylase inhibitor to receive FDA approval, also for multiple myeloma; and palbociclib (Ibrance), the first drug in a new class of cyclin-dependent kinase (CDK) 4 and CDK 6 selective inhibitors, in the treatment of metastatic breast cancer. Among the new drug indications approved by the FDA so far this year are pembrolizumab (Keytruda) for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express p rogrammed cell death ligand 1 continued on page 42
Perspective
ASCO Guideline on the Use of Biomarkers in Treatment Decisions in Metastatic Breast Cancer: Shedding Light on an Often Mysterious Art By Elizabeth Reed, MD
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Filial Gaze at Our Noble Profession
s summarized in this issue of The ASCO Post (see page 70), Van Poznak and colleagues recently published an ASCO clinical practice guideline on the use of biomarkers for decisions regarding systemic therapy in women with metastatic breast cancer.1 This new guideline updates the previous ASCO biomarker
guideline, which addressed all indications in breast cancer for biomarker assays.2 The newest guideline builds upon the ASCO and the College of American Pathologists two guidelines on testing for human epidermal growth factor receptor 2 (HER2) and endocrine receptors for estrogen and progesterone.3-5 Van Poznak et al addressed the use of biomarkThe panel should be commended ers in selecting treatment for gleaning the data from a limited for metastatic breast cancer on the basis of estrogen number of trials and lending its receptor, progesterone regreat clinical experience to publish ceptor, and HER2 status, as well as considering evaluaa guideline that enlightens the tion of response to therapy often mysterious art of managing using assays for carcinoembryonic antigen, cancer metastatic breast cancer. antigen 15-3 (CA 15-3), —Elizabeth Reed, MD
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s we stood outside patient X’s room going over the vitals, from a distance, I saw the father of the patient by the side of her bed. I saw him standing there and looking down at his child conveying what I guess were words of reassurance and reinforcing the pillars of strength needed for her recovery. It appeared like he was not saying much, but his silence, punctuated by a few words and combined with that affectionate and elegiac gaze, was enough to make her look comfortable. It is difficult for patient X to do anything on her own due to the severity of her illness. Even continued on page 164
Dr. Are is Jerald L & Carolynn J Varner Professor of Surgical Oncology & Global Health; Vice Chair of Education; and Program Director, General Surgery Residency, University of Nebraska Medical Center, Omaha. Disclaimer: This commentary represents the views of the author and may not necessarily reflect the views of ASCO.
MORE IN THIS ISSUE Oncology Meetings Coverage Lynn Sage Breast Cancer Symposium ��� 3, 4 Palliative Care Symposium ����������� 5, 10–14 Breast Cancer Symposium ����������������� 15–16 JADPRO Live at APSHO �����������������18–20 Society of Integrative Oncology �������22–23 Geriatrics for the Oncologist �������������������27 Direct From ASCO �������������������������� 85–88 Global Cancer Burden: Argentina ��92–93 Barry R. Meisenberg, MD, on Costs, Outcomes, and Expectations ��������������������� 99 Foot Care in Oncology �������������������������� 106 Liver Mets in Colon Cancer ������������������ 148 In Memoriam: Mary Pazdur, RN, MSN ���������������162–163
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