CHMP recommends Xgeva to treat to treat skeletal-related events in patients with multiple myeloma. Amgen.

Amgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion to expand the current indication for Xgeva (denosumab) to cover skeletal-related events in patients with multiple myeloma. If approved, Xgeva will be indicated for the prevention of skeletal-related events in adults with advanced malignancies involving bone.

The application included new data from the Phase III '482 study, the largest international multiple myeloma trial for the prevention of skeletal-related events ever conducted. In the '482 study, Xgeva successfully met the primary endpoint, demonstrating non-inferiority to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma (HR=0.98, 95 percent CI: 0.85-1.14). The median time to first on-study skeletal-related event was 22.83 months for Xgeva and 23.98 months for zoledronic acid. The safety profile was consistent with known adverse events of Xgeva.