Prostate Cancer: FDA Votes Against Amgen's Xgeva
A panel of cancer experts has voted against a new use for Amgen's Xgeva in prostate cancer, 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.
Xgeva is already approved for preventing fractures in cancerous bones, and for osteoporosis, in a different formulation called Prolia.
Amgen 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.