Xgeva Approved to Prevent Skeletal-Related Events in Multiple Myeloma Patients

The approval is based on data from the pivotal Phase 3 '482 study, the largest international multiple myeloma clinical trial ever conducted.

Amgen announced that the Food and Drug Administration (FDA) has expanded the indication for Xgeva (denosumab) to include the prevention of skeletal-related events in patients with multiple myeloma. 

The FDA approval was supported by data from the Phase 3, randomized, double-blind, multicenter ‘482 study (n=1,718) that compared Xgeva with zoledronic acid for the prevention of skeletal-related events in adults with newly diagnosed multiple myeloma and bone disease. The primary endpoint was non-inferiority of Xgeva vs zoledronic acid with respect to time to first on-study skeletal-related event (eg, pathologic fracture, radiation to bone, surgery to bone or spinal cord compression); secondary endpoints included superiority of Xgeva with respect to time to first on-study skeletal-related event and first-and-subsequent on-study skeletal-related event and evaluation of overall survival. 

Study data showed Xgeva was non-inferior to zoledronic acid as it delayed the time to first on-study skeletal-related event in patients with multiple myeloma (hazard ratio [HR] 0.98, 95% CI: 0.85, 1.14; P=0.01). However, the secondary endpoints did not demonstrate superiority. The two treatment arms demonstrated similar overall survival rates (HR 0.90, 95% CI: 0.70, 1.16; P=0.41). 

The safety profile of Xgeva-treated study patients was similar to the known safety profile with the most common adverse events being diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. 

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Xgeva, an osteoclast inhibitor (RANKL inhibitor), is already indicated to prevent skeletal-related events in patients with bone metastases from solid tumors; to treat hypercalcemia of malignancy refractory to bisphosphonate therapy; and to treat adults and skeletally-mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. 

Noopur Raje, MD, director, Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center, Boston, stated, “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.”

For more information call (800) 772-6436 or visit Xgeva.com.