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Regulation
Amgen likely needs new trial of Xgeva to prevent bone mets in prostate cancer
Waiting for Xgeva
By Aaron Bouchie
Senior Writer
Published on
Monday, February 13, 2012
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.
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