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Journal of the National Cancer Institute Advance Access originally published online on September 23, 2008
JNCI Journal of the National Cancer Institute 2008 100(19):1344-1351; doi:10.1093/jnci/djn358
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© Oxford University Press 2008.

NEWS

ESAs Further Restricted, but Debate Continues

Vicki Brower

The first 150 words of the full text of this article appear below.

The best-selling oncology drugs in the United States, erythropoiesis-stimulating agents (ESAs), have been taken by about half of all U.S. cancer patients to treat chemotherapy-induced anemia—more than the number receiving radiation therapy. But that is changing.

This summer, European and American regulatory authorities stringently restricted who should take ESAs, the most recent in a series of steps taken in response to clinical trials and basic research indicating that ESAs may harm cancer patients. Last year, the Centers for Medicare and Medicaid Services began denying coverage for the use of ESAs in cancer patients not undergoing chemotherapy and in those whose hemoglobin level is 10 g/dL or above. The center has further restricted use of darbepoetin, a second-generation, extended-release version, in patients undergoing chemotherapy.

ESAs include epoetin alfa (Amgen's Epogen and Procrit, which is manufactured by Amgen but licensed to Johnson & Johnson's Ortho Biotech), Amgen's longer-lasting darbepoetin alfa (Aranesp), and, . . . [Full Text of this Article]

Labeling Changes Ordered

A Troubled History

Responses to Restrictions

EPO's Dark Side

Follow the Money

ESA Timeline


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