Amgen files requests to expand Xgeva's use in U.S. and Europe

Amgen has submitted a supplemental Biologics License Application (sBLA) for Xgeva (denosumab) to the U.S. Food and Drug Administration along with approval requests to the European Medicines Agency.
Amgen seeks to expand Xgeva’s approved capabilities to include the prevention of skeletal-related events in solid tumors to include patients with multiple myeloma.
"Bone lesions are a hallmark of multiple myeloma and often result in bone complications, which can be devastating for patients," Dr. Sean Harper, Amgen's executive vice president of research and development, said. "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."
Harper claimed that Xgeva’s unique properties provide patients with a way to treat their multiple myeloma symptons with a non-renal method.
“We look forward to collaborating with regulatory authorities to make Xgeva available to this patient population with an important unmet medical need,” Harper said.