The US Food and Drug Administration (FDA) approved a supplemental Biologics License Application to expand the indication of denosumab to include patients with multiple myeloma, according to a press release.1

Denosumab was previously indicated for skeletal-related event prevention among patients with bone metastases from solid tumors.

The FDA based its approval on results from the double-blind phase 3 ‘482 study ( Identifier: NCT01345019), for which researchers randomly assigned 1718 newly diagnosed patients to receive subcutaneous denosumab 120 mg or intravenous zoledronic acid 4 mg every 4 weeks.

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Denosumab was non-inferior to zoledronic acid in delaying the time to first on-study skeletal related event (hazard ratio [HR], 0.98; 95% CI, 0.85-1.14; P = .01), achieving the study’s primary endpoint.

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Secondary endpoints, including superiority of denosumab to zoledronic acid in delaying time to first skeletal-related event and delaying time to first- and subsequent skeletal-related events, were not met.

The overall survival was similar for patients in both study arms (HR, 0.90; 95% CI, 0.70-1.16; P = .41). The median progression-free survival (PFS) for patients in the denosumab arm was 46.1 months (95% CI, 34.4-not evaluable) compared with 35.4 months (95% CI, 30.2-not evaluable) for patients treated with zoledronic acid (HR, 0.82; 95% CI, 0.68-0.99; descriptive-P = .036).

Denosumab is not cleared though the kidneys, providing patients with renal impairment — who are at high risk of developing bone complications — a novel therapeutic modality. Compared with zoledronic acid, patients treated with denosumab had lower rates of renal adverse events (17.1% vs 10.0%, respectively; P < .001).

The most frequently reported adverse events included diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, and upper respiratory tract infection.


  1. FDA approves XGEVA (denosumab) for the prevention of skeletal-related events in patients with multiple myeloma [news release]. Thousand Oaks, CA: Amgen; January 5, 2017. Accessed January 5, 2017.