April 4, 2017
Amgen has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and an application for a variation to the marketing authorization to the European Medicines Agency (EMA) for XGEVA® (denosumab). These submissions to regulatory authorities seek to expand the currently approved XGEVA indication for the prevention of skeletal-related events (SREs) in solid tumors for including patients with multiple myeloma. The applications include new data from the pivotal Phase 3 head-to-head ‘482 study, which is the largest international multiple myeloma trial ever conducted.
Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, said: “Bone lesions are a hallmark of multiple myeloma and often result in bone complications, which can be devastating for patients. Current treatment options for bone complications are limited to bisphosphonates, which are associated with renal toxicity. Approximately 60 percent of all multiple myeloma patients have or will develop renal impairment over the course of the disease. XGEVA’s unique mechanism of action may offer multiple myeloma patients a novel treatment option that is not renally cleared. We look forward to collaborating with regulatory authorities to make XGEVA available to this patient population with an important unmet medical need.”