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Amgen (AMGN) Fails to Win Panel Backing for Expanded Xgeva Use FDA


2/9/2012 8:10:58 AM

Amgen Inc., the world’s biggest biotechnology company, failed to win the backing of a U.S. advisory panel for its drug to delay tumors spreading to bones in patients with advanced prostate cancer. The panel voted 12-1 that the risks outweighed the benefits of the drug, Xgeva. Food and Drug Administration staff questioned in a Feb. 6 report whether the ability to delay tumor growth in bones is enough to justify approval. The drug, known chemically as denosumab, didn’t extend lives in a study.

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