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FDA Approves Denosumab for Multiple Myeloma

Jason M. Broderick @jasoncology
Published: Friday, Jan 05, 2018

The FDA has approved 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.

Adverse events (AEs) in the study were consistent with the known safety profile for denosumab. The most common AEs in the denosumab arm were diarrhea (33.5% vs 32.4% with zoledronic acid) and nausea (31.5% vs 30.4%).


Zoledronic acid has been a standard of care for patients with multiple myeloma for the prevention of SREs, since it was approved in 2002. In a 1018-patient study,1 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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