FDA Approves XGEVA ® (denosumab) For The Prevention Of Skeletal-Related Events In Patients With Multiple Myeloma

Expansion of Indication Offers Patients a New Treatment Option Approval Based on Safety and Efficacy Data From the Largest International Multiple Myeloma Clinical Trial Ever Conducted THOUSAND OAKS, Calif., Jan. 5, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (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 tumors to include patients with multiple myeloma. The approval is based on data from the pivotal Phase 3 '482 study, the largest international multi...
Source: Amgen News Release - Category: Pharmaceuticals Tags: Uncategorized Source Type: news