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Amgen: FDA To Review SBLA To Expand Indication For XGEVA - Quick Facts

Amgen (AMGN) announced the U.S. FDA has accepted the XGEVA (denosumab) supplemental Biologics License Application that seeks to expand the currently approved indication for the prevention of fractures and other skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma. The FDA has set a PDUFA action date of Feb. 3, 2018.

Amgen said its sBLA, submitted on April 3, 2017, is based on the efficacy and safety data from the pivotal Phase 3 '482 study, which successfully demonstrated that XGEVA is non-inferior to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma. The secondary endpoints of superiority in delaying time to first on-study skeletal-related event and delaying time to first-and-subsequent skeletal-related event were not met in the study.

by RTT Staff Writer

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