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FDA Accepts Denosumab sBLA for Multiple Myeloma

Jason M. Broderick @jasoncology
Published: Monday, Jun 19, 2017

Dr. Sean E. Harper

Sean E. Harper, MD
The FDA has accepted a supplemental biologics license application (sBLA) for the use of denosumab (Xgeva) for the prevention of skeletal-related events (SREs) in patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor.

zoledronic acid reduced the risk of death by 22% and SREs by 25% compared with the bisphosphonate pamidronate in multiple myeloma. The median OS with zoledronic acid was 32.4 months compared with 23.4 months with pamidronate (HR, 0.78; 95% CI, 0.67-0.92).

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