European Commission approves expanded indication for Xgeva for the prevention of skeletal-related events in adults with advanced malignancies involving bone metastases from solid tumors and those with multiple myeloma.- Amgen

Amgen has announced that the European Commission (EC) has approved an expanded indication for Xgeva (denosumab) for the prevention of skeletal-related events in adults with advanced malignancies involving bone. The indication now covers patients with bone metastases from solid tumors and those with multiple myeloma.

The approval is based on data from the Phase III '482 study, the largest international trial ever conducted for the prevention of skeletal-related events in multiple myeloma patients. In the Phase III '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 22.8 months for Xgeva and 24.0 months for zoledronic acid. The safety profile was consistent with known adverse events of Xgeva.