BRIEF—FDA approves new indication for Xgeva

The US Food and Drug Administration has approved the supplemental Biologics License Application (sBLA) for biotech major Amgen’s Xgeva (denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.

The approval is based on data from the pivotal Phase III '482 study, the largest international multiple myeloma clinical trial ever conducted, which enrolled 1,718 patients.

"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," Dr Raje added.

"Bone complications can be devastating for patients with multiple myeloma. Previously, treatment options for the prevention of bone complications were limited to bisphosphonates, which unlike Xgeva, are cleared by the kidneys," said David Reese, senior vice president of translational sciences and oncology at Amgen.