On May 10, 2007, the Food and Drug Administration (FDA) conveneda meeting of its Oncology Drug Advisory Committee to discussconcerns about risks associated with the erythropoiesis-stimulatingagents (ESAs) used to treat anemia caused by chemotherapy. Theprincipal ESAs under scrutiny were epoetin alfa (Procrit, Eprex,and Epogen) and darbepoetin alfa (Aranesp), and the risks —actual or potential — were thromboembolic disease, promotionof tumor growth, and decreased survival. The actual risk ofthromboembolic events was shown in two phase 3 clinical trials,reported in the Journal in 2006, that unequivocally showed anincreased risk of death or . . . [Full Text of this Article]
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Dr. Khuri is a professor and the section head of hematology and medical oncology at the Emory Winship Cancer Institute, Atlanta.
An interview with James Doroshow, director of the Division of Cancer Treatment and Diagnosis at the National Cancer Institute, can be heard at www.nejm.org.
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