Amgen announced that the Food and Drug Administration (FDA) has approved Xgeva (denosumab) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy.

The new approval is supported by results from an open-label, single-arm study that studied patients with advanced cancer and persistent hypercalcemia after recent bisphosphonate therapy. The primary endpoint was the proportion of patients with a response (defined as albumin-corrected serum calcium <11.5mg/dL) within 10 days after the first Xgeva dose. The study achieved its primary endpoint with a response rate of 63.6% at Day 10 in the 33 enrolled patients. The estimated median time to response was 9 days, and the median duration of response was 104 days.

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Xgeva is already approved for treatment of 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, and prevention of skeletal-related events (SRE) in patients with bone metastases from solid tumors.

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