NCI Cancer Bulletin: A Trusted Source for Cancer Research News
NCI Cancer Bulletin: A Trusted Source for Cancer Research News
March 18, 2008 • Volume 5 / Number 6 E-Mail This Document  |  Download PDF  |  Bulletin Archive/Search  |  Subscribe

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FDA Update

FDA Advisory Committee Recommends Further Limits on
Use of ESAs

On March 13, the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended substantially limiting the use of erythropoiesis-stimulating agents (ESAs) to treat anemia in cancer patients. The panel made the recommendation after hearing additional evidence from a recently published meta-analysis showing that ESAs increase the risk of blood clots and death in patients taking the drugs for chemotherapy-induced anemia.

The committee recommended that the drugs be restricted to cancer patients with advanced disease; that the drugs not be used in patients with breast or head and neck cancer, the cancer types with the most evidence of severe side effects; and that patients be required to complete a written consent before using ESAs.

This was the third ODAC meeting held to discuss safety concerns about ESAs. The FDA isn't required to adopt the advisors' recommendations, but agency representatives indicated during the ODAC meeting that they are likely to adopt further restrictions on the use of ESAs. There are currently three FDA-approved ESAs on the U.S. market: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa).