FDA panel to review potential new use for Xgeva

THOUSAND OAKS, Calif. — Drug maker Amgen will discuss the supplemental biologics license application of Xgeva before a Food and Drug Administration review panel next month.

Amgen will participate in a meeting of the Oncologic Drugs Advisory Committee on Feb. 8, where the panel will review results from clinical studies in support of Xgeva as a treatment of castration-resistant prostate cancer in men that are at high risk of developing bone metastases, a new indication for the drug. The company said there currently is no approved treatments to delay or prevent the spread of cancer to bone among this specific patient population.

The sBLA was submitted this past June, and a Prescription Drug User Fee Act action date has been scheduled for April 26 of this year. If approved, this will be the second indication of Xgeva in the United States.


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