US regulators have expanded the scope of Amgen’s Xgeva to include the prevention of skeletal-related events in patients with multiple myeloma.
The drug was approved to prevent skeletal complications in patients with bone metastases from solid tumors back in 2010.
Its expansion rides on the back of Phase III data showing that Xgeva (denosumab) is non-inferior to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma.
Overall survival was comparable between the two treatment arms, but the median difference in progression-free survival favored Xgeva by 10.7 months, Amgen noted.
"Up to 40 percent of patients remain untreated for the prevention of bone complications, and the percentage is highest among patients with renal impairment at the time of diagnosis," said Noopur Raje, director, Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center, Boston.
"Denosumab, which is not cleared through the kidneys, offers multiple myeloma patients bone protection with a convenient subcutaneous administration, providing patients with a novel treatment option."