Posted by Michael Wonder on 06 Jan 2018
FDA approves Xgeva (denosumab) for the prevention of skeletal-related events in patients with multiple myeloma
5 January 2018 - Approval based on safety and efficacy data from the largest international multiple myeloma clinical trial ever conducted.
Amgen today announced that the U.S. FDA has approved the supplemental Biologics License Application (sBLA) for Xgeva (denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumours to include patients with multiple myeloma.
The approval is based on data from the pivotal Phase 3 '482 study, the largest international multiple myeloma clinical trial ever conducted, which enrolled 1,718 patients.
