FDA Complete Response Letter to Xgeva application to treat high risk Prostate Cancer bone metastases

The FDA has issued a Complete Response Letter for the supplemental Biologics License Application for Xgeva (denosumab) from Amgen to treat men with castration-resistant Prostate Cancer at high risk of developing bone metastases.The Complete Response Letter states that the FDA cannot approve the application in its present form. The FDA determined that the effect on bone metastases-free survival was of insufficient magnitude to outweigh the risks (including osteonecrosis of the jaw) of Xgeva in the intended population, and requested data from an adequate and well-controlled trial(s) demonstrating a favorable risk-benefit profile for Xgeva that is generalizable to the U.S. population.The FDA's action does not impact the approved indication of Xgeva in the prevention of skeletal-related events in men with bone metastases from Prostate Cancer, which was acknowledged by the FDA and the advisory committee members who discussed the application.