FDA commentary and panel members' votes at last week's review of Xgeva denosumab from Amgen Inc. make it clear companies working in pre-metastatic CRPC will be held to standards first discussed publicly at a September 2011 panel, regardless of when their trials began.

FDA's Oncologic Drugs Advisory Committee voted 12-1 that Xgeva has not demonstrated a favorable benefit-risk profile for treating pre-metastatic castration-resistant prostate cancer because Amgen did not provide data showing that treatment before metastasis provides a greater benefit than waiting to treat until after metastases appear. Xgeva is approved for the latter indication.