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FDA Approval Sought for Denosumab in Myeloma

Jason M. Broderick @jasoncology
Published: Wednesday, Apr 05, 2017

Dr. Sean E. Harper

Sean E. Harper, MD

A supplemental biologics license application (sBLA) has been submitted to the FDA 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.

In addition to other approvals, denosumab is currently indicated for the prevention of SREs in patients with bone metastases from a solid tumor, based upon 3 large studies comparing the agent with zoledronic acid in 5723 patients.2 Across these trials, the median time to first SRE was 27.7 months with denosumab compared with 19.5 months with zoledronic acid (HR, 0.83; 95% CI, 0.76-0.90; P <.001).

 
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