February 9, 2012

FDA panel votes against Xgeva for prostate cancer


panel of cancer experts voted against a new use for Amgen's Xgeva in prostate cancer on Wednesday, saying the drug's ability to slow the spread of the disease did not translate into meaningful benefits for patients.The Food and Drug Administration's cancer drug panel voted 12-1 that the benefits of the drug did not outweigh its risks, which included bone disease in about 6 percent of patients. The FDA is not required to follow the group's advice, though it often does…"The effect of the studied compound is quite weak with no effect on survival or the overall course of the disease in general," said Dr. Ronald Richardson of the Mayo Clinic. All of the panel's physicians voted against the company's application. The lone patient representative on the panel voted in favor.

AP, by Matthew Perrone, 02/08/2012

Tags: amgen, Cancer, cancer drug panel, Dr. Ronald Richardson, FDA, Food and Drug Administration, prostate cancer, Xgeva

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