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Denosumab Approaches European Approval for Myeloma

Jason Harris
Published: Friday, Feb 23, 2018

David M. Reese, MD

David M. Reese, MD
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval 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.

The most common grade ≥3 treatment-emergent AEs for both the denosumab and zoledronic acid groups were neutropenia (15% for both) thrombocytopenia (14% vs 12%), anemia (12% vs 10%), febrile neutropenia (11% vs 10%), and pneumonia (8% for both) The most common serious AE for both treatment groups was pneumonia (8% for both). One patient in the zoledronic acid group died of cardiac arrest that was deemed treatment-related.
Raje N, Terpos E, Willenbacher W, et al. Denosumab versus zoledronic acid in bone disease treatment of newly diagnosed multiple myeloma: an international, double-blind, double-dummy, randomised, controlled, phase 3 study [published online February 9, 2018]. Lancet Oncol. doi/10.1016/ S1470-2045(18)30072-X.

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