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# Amgen sBLA for Xgeva Expanded Indication
- URL: https://www.fdaweb.com/amgen-sbla-for-xgeva-expanded-indication/
- Published: 2017-04-04T12:00:00.000Z
- Updated: 2026-09-14T22:15:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138368

Amgen has submitted a supplemental BLA for Xgeva (denosumab) to expand its use for preventing skeletal-related events (SREs) in solid tumors to include patients with multiple myeloma. The application includes new data from the pivotal Phase 3 head-to-head 482 study. demonstrated that XGEVA is non-inferior to zoledronic acid (Novartis’ osteoporosis drug Reclast) in delaying the time to first on-study SRE in patients with multiple myeloma, Amgen says. “The secondary endpoints of superiority in delaying time to first SRE and delaying time to first-and-subsequent SRE were not met in this study,” it says, adding that overall survival was also in Xgeva’s favor.

  
Xgeva is a human monoclonal antibody that binds to and neutralizes RANK ligand, “a protein essential for the formation, function and survival of osteoclasts, which break down bone — thereby inhibiting osteoclast-mediated bone destruction,” the company says. Xgeva is currently indicated for the prevention of SREs in patients with bone metastases from solid tumors based on results from three previous pivotal Phase 3 head-to-head studies.