Amgen files for expanded use of Xgeva in USA and Europe

US biotech major Amgen (Nasdaq: AMGN) has filed a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration and an application for a variation to the marketing authorization to the European Medicines Agency (EMA) for Xgeva (denosumab).

The submissions to regulatory authorities seek to expand the currently approved Xgeva indication for the prevention of skeletal-related events (SREs) in solid tumors to include patients with multiple myeloma. The applications include new data from the pivotal Phase III head-to-head '482 study, the largest international multiple myeloma trial ever conducted.

"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," said Sean Harper, executive vice president of R&D at Amgen.