FDA extends denosumab approval to include MM patients with bone lesions

The Food and Drug Administration (FDA) approves the supplemental Biologics License Application for denosumab (Xgeva, Amgen) to expand the currently approved indication for the prevention of skeletal-related events in multiple myeloma (MM) patients with bone metastases. The approval is based on data from the pivotal phase III randomized, double-blind, multicenter ‘482 trial, the largest international MM clinical trial, which enrolled 1,718 patients. The study met the primary endpoint, demonstrating non-inferiority of denosumab to zoledronic acid in delaying the time to first on-study skeletal-related event in MM patients (HR = 0.98; 95% CI: 0.85–1.14; P = .01). The secondary endpoints, delaying time to first skeletal-related event and delaying time to first-and-subsequent skeletal-related events, did not demonstrate superiority. Overall survival was comparable between denosumab and zoledronic acid, with an HR of 0.90 (95% CI: 0.70–1.16; P = .41). The median difference in progression-free survival (PFS) favored denosumab by 10.7 months (HR = 0.82; 95% CI: 0.68, 0.99; P = .036). Median PFS was 46.1 months (95% CI: 34.3 months, not estimable [NE], n = 219) for denosumab and 35.4 months (95% CI: 30.2 months, NE, n = 260) for zoledronic acid. Adverse events observed in patients treated with denosumab were generally consistent with the known safety profile of this drug.

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