Amgen’s Xgeva For Castration-Resistant Prostate Cancer Faces Panel Review Without Overall Survival Advantage

Delaying or preventing bone metastasis is an important clinical benefit for patients, an FDA official said recently. The Oncologic Drugs Advisory Committee will share its opinion about the product on Feb. 8.

Amgen Inc. will have to rely on the fact that FDA accepts many applications in advanced metastatic disease that rely on less clinically meaningful endpoints than overall survival due to the difficulty of developing treatments when its monoclonal antibody Xgeva (denosumab) comes up for advisory panel review.

The Oncologic Drugs Advisory Committee will examine the company’s proposed indication for men with castrate-resistant prostate cancer at high risk...

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