The U.S. Food and Drug Administration (FDA) has approved Amgen’s 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 tumors 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. ...