FDA clears Amgen’s bone drug for multiple myeloma
Amgen has announced that the FDA has approved the indication expansion of its drug Xgeva (denosumab) to include the treatment of multiple myeloma, adding to its previous indication for the prevention of skeletal-related events in patients with bone metastases from solid tumours.
The decision was based on positive data generated from 1,718 participants in a Phase 3 clinical trial – the largest international multiple myeloma study ever conducted. Xgeva met its primary endpoint, proving its non-inferiority to zoledronic acid in delaying the onset of skeletal-related events in adult patients newly diagnosed with multiple myeloma.
Xgeva is a fully human monoclonal antibody which functions by binding to and neutralising RANK ligand (RANKL), a protein which governs the formation and function of osteoclasts, inhibiting osteoclast-mediated bone destruction. However, the drug failed to show superiority in delaying first skeletal-related events and first and subsequent skeletal-related events. Overall survival between Xgeva and zoledronic acid was shown to be comparable, and median progression-free survival was 46.1 months.
“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 M Reese, Senior Vice President of Translational Sciences and Oncology at Amgen. “We are pleased that the FDA has approved the expanded indication for Xgeva, providing a new option for patients and physicians, underscoring our commitment to advancing care for patients with multiple myeloma.”
Noopur Raje, Director of the Center for Multiple Myeloma at Massachusetts General Hospital Cancer Center, also commented on the expanded approval, noting: “Up to 40% 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. 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.”
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