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 of developing bone metastases when it meets Feb. 8. Filed last June 27, the PDUFA date for this indication is April 26
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