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Continuing Reassessment of the Risks of Erythropoiesis-Stimulating Agents (ESAs) in Patients with Cancer Vinni Juneja, MD Division of Biologic Oncology Products Credits Chaohong Fan Patricia Keegan Mark Rothmann Yuan Li Shen Kyung Lee Monica Hughes Outline Introduction Regulatory History Benefits vs Risks of ESAs Safety signals leading to ODAC May 2004 ODAC 2004 Data from Recent Trials since ODAC 2004 “Meta Analyses” considerations Continuing assessment of ESA risks vs benefits Risks of ESAs in Cancer Patients Decreased Survival Tumor Promotion Decreased locoregional control Decreased progression free survival? Increased thrombovascular events (TVEs) ESAs for Chemotherapy-associated Anemia Class Effect of ESAs FDA considers all ESAs as members of the same product class Risks of ESAs apply to all products Outline Introduction Regulatory History Benefits vs Risks of ESAs Safety signals leading to ODAC May 2004 ODAC 2004 Data from Recent Trials since ODAC 2004 “Meta Analyses” considerations Procrit/Epogen (epoetin alfa) Epoetin alfa products licensed in the U.S. are manufactured by Amgen EPOGEN distributed by Amgen → Dialysis pts PROCRIT distributed by Ortho Biotech (subsidiary of JJ) → all other indications EPOGEN and PROCRIT labeling is identical Procrit/Epogen (epoetin alfa) Non-cancer Approvals 1988-anemia of Chronic Renal Failure 1991-AZT related anemia in AIDS 1995-reduction of perioperative transfusion Cancer Approvals 1993-Anemia associated with chemo June 2004-Weekly dosing in Anemia with chemo Revisions to Label May 2004-Effects on RR, TTP, and OS in solid tumors Approval of Procrit/Epogen: 1993 Approved for cancer patients on chemotherapy based on reduction in % pts transfused Infectious risks of blood transfusion in 1993 higher than in 2007 Pooled data from 6 randomized, double blind, placebo controlled trials in a total of 131 patients, with different malignancies was basis for approval. Theoretical potential for tumor promotio