Xgeva Prostate Cancer Claim May Not Benefit Beyond Existing Cancer Indication, FDA Says

FDA questions whether an indication for Amgen Inc.’s Xgeva (denosumab) to delay bone metastases in men with castrate-resistant prostate cancer at high risk for such metastases would provide benefit beyond that seen with current use of the biologic to prevent skeletal-related events in solid tumors metastatic to bone.

The pivotal trial (20050147) for the castrate-resistant prostate cancer (CRPC) indication was not designed to demonstrate that administering “denosumab prior...