FDA Accepts Amgen's Supplemental Biologics License Application To Expand Indication For XGEVA ® (denosumab) To Include Multiple Myeloma Patients

FDA Sets PDUFA Target Action Date of Feb. 3, 2018 THOUSAND OAKS, Calif., June 19, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the XGEVA® (denosumab) supplemental Biologics License Application (sBLA) that seeks to expand the currently approved indication for the prevention of fractures and other skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of Feb. 3, 2018. "Multiple myeloma patients with fractures and other bone complications have a very poor progn...
Source: Amgen News Release - Category: Pharmaceuticals Tags: Uncategorized Source Type: news