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The Boston Globe

Business

FDA cancer panel rejects Amgen drug

WASHINGTON - A panel of cancer specialists voted against a new use for Amgen’s Xgeva in prostate cancer yesterday, 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.

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Xgeva is already approved to prevent fractures in cancerous bones, and for osteoporosis, in a different formulation called Prolia.

Amgen Inc. has asked the FDA to approve the injectable drug as a preventive measure for men with recurring prostate cancer that is at high risk of spreading to the bone. At the public meeting yesterday, Amgen scientists pointed to results of a company study showing patients taking Xgeva experienced a four-month delay in the spread of cancer to the bones around the prostate.

Panelists termed this a “statistical benefit,’’ but not one that resulted in increased survival or higher quality of life for patients.

Many cancer drugs approved do not actually extend survival, but instead slow the growth of tumors. In recent years, cancer specialists have debated the meaningfulness of these measures. Panel chairman Dr. Wyndham Wilson acknowledged that delaying the disease’s spread to the bone could be meaningful, but suggested the drug would have to do so for more than four months.

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