Posted by Michael Wonder on 04 Apr 2018
European Commission approves expanded indication for Amgen's Xgeva (denosumab) for the prevention sf skeletal-related events in patients with multiple myeloma
2 April 2018 - This approval was based on the largest international trial ever conducted for the prevention of skeletal-related events in multiple myeloma patients.
Amgen today announced that the European Commission 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 tumours and those with multiple myeloma.
The approval is based on data from the Phase 3 '482 study, the largest international trial ever conducted for the prevention of skeletal-related events in multiple myeloma patients.
