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

The agency will ask the Oncologic Drugs Advisory Committee whether delaying bone metastases in high-risk castrate-resistant prostate cancer patients provides benefit above that obtained with current use of t drug to delay skeletal-related events and is worth a potentially higher risk for osteonecrosis of the jaw.

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...

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