Amgen asks FDA to consider new uses for Xgeva
Thousand Oaks-based biotech giant Amgen announced June 19 that the U.S. Food and Drug Administration has accepted a supplemental application for Xgeva (denosumab) 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.
“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, 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.”
Amgen shares closed June 19 at $165.09, up $2.67 or 1.6 percent.