The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to 1 that the risk-benefit ratio was insufficient for an expanded use of denosumab (Xgeva) to delay the spread of prostate cancer to the bone in men with castration-resistant disease. The panel was not asked specifically whether it recommended approval for this expanded indication. The FDA will make a final decision by April 26, 2012.
According to the panel, the drug’s benefits were outweighed by the possibility of increased toxicity, particularly osteonecrosis of the jaw, with long-term use. The patient representative was the only ODAC panelist to vote in favor of approval for the new indication. ■