FDA Approval Alert: Expanded Indication for Denosumab


The US Food and Drug Administration (FDA) has expanded the approval of denosumab (Xgeva, Amgen) for the prevention of skeletal-related events in patients with bone metastasis from multiple myeloma.

Approval is based on data from a phase III trial, which sampled 1718 patients to receive either subcutaneous denosumab (120 mg) or zoledronic acid (4 mg). Results of the study showed that denosumab was non-inferior to zoledronic acid in delaying the time to first on-study skeletal-related events in patients with multiple myeloma (HR, 0.98; 95% CI, 0.85-1.14; P = .01).

Adverse events observed in the study for patients receiving denosumab were consistent with the known safety profile of the drug.


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"Up to 40% of patients remain untreated for the prevention of bone complications, and the percentage is highest among patients with renal impairment at the time of diagnosis," said Noopur Raje, MD, director, Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center, in a press release (December 5, 2018). "Denosumab, which is not cleared through the kidneys, offers multiple myeloma patients bone protection with a convenient subcutaneous administration, providing patients with a novel treatment option."—Zachary Bessette