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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