Amgen hoping to extend use of Xgeva to prevent fractures in myeloma patients
Based on data from an international clinical trial, U.S. drugmaker Amgen has petitioned the Food and Drug Administration to allow use of Xgeva (denosumab) to prevent bone fractures among multiple myeloma patients.
Xgeva has previously been prescribed to help protect bones from cancer that spreads from solid tumors, and Amgen wants to extend its use to patients with myeloma, a type of cancer originating in the patient’s blood cells.
Xgeva is a bisphosphonate that disrupts a chain reaction in the body that weakens the bones of cancer patients, Amgen said in a release. The Phase 3 trial that identified Xgeva's potential new use saw subjects survive nearly 11 months longer than patients treated with zoledronic acid, a previously available treatment.
Dr. Sean Harper, the company’s executive vice president of research and development, said Xgeva may help patients with few treatment options for the difficult-to-treat disease.
"Multiple myeloma patients with fractures and other bone complications have a very poor prognosis,” Harper said in the release. “Bisphosphonates are the only approved class of agents for the prevention of skeletal-related events in this patient population. 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."
Organizations in this story
Amgen Inc. 1 Amgen Center Dr Thousand Oaks, CA 91320
U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD 20903