Amgen announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for XGEVA (denosumab) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy. Xgeva was approved and granted Orphan Drug Designation by the FDA, which is reserved for drugs that are intended for the treatment of rare diseases affecting fewer than 200,000 people in the U.S.
HCM is a serious complication in patients with advanced cancer, including those with hematologic malignancies, and indicates poor prognosis. The condition results from cancer-driven increases in bone resorption, and if untreated, can lead to renal failure, progressive mental impairment, coma and death.
“Our continued study of xgeva reinforces Amgen’s ongoing commitment to address the unmet needs of cancer patients,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “This latest FDA approval for xgeva provides an important new therapeutic option for patients with a rare condition that cannot be resolved with bisphosphonate therapy.”