FDA accepts Xgeva (denosumab) sBLAto expand the currently approved indication to include patients with multiple myeloma.- Amgen

Amgen announced that the 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 3 February, 2018 .

"Multiple myeloma patients with fractures and other bone complications have a very poor prognosis. Bisphosphonates are the only approved class of agents for the prevention of skeletal-related events in this patient population. However, these agents have several limitations, including kidney toxicity and acute phase reactions," said Sean E. Harper , M.D., executive vice president of Research and Development at Amgen . "Based on the data we have submitted to the FDA , we look forward to potentially making Xgeva available as a novel option for patients with multiple myeloma."

The sBLA, submitted on 3 April 2017 , is based on the efficacy and safety data from the pivotal Phase III '482 study, the largest international multiple myeloma trial ever conducted, which successfully demonstrated that Xgeva is non-inferior to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma. The secondary endpoints of superiority in delaying time to first on-study skeletal-related event and delaying time to first-and-subsequent skeletal-related event were not met in this study. Progression-free survival was an exploratory endpoint. The hazard ratio of Xgeva versus zoledronic acid for progression-free survival was 0.82 (95 percent CI: 0.68, 0.99; descriptive p=0.036) and the median difference in progression-free survival between arms was 10.7 months in favor of Xgeva. Data from the '482 study are also the basis of an application for a variation to the marketing authorization submitted to the European Medicines Agency (EMA).