FDA approves Xgeva for Hypercalcemia of Malignancy-Amgen

The FDA has approved a new indication for Xgeva (denosumab), from Amgen, for the treatment of Hypercalcemia of Malignancy (HCM) refractory to bisphosphonate therapy. Xgeva was also granted Orphan Drug Designation by the FDA. The approval of XGEVA is based on positive results from an open-label, single-arm study, which enrolled patients with advanced cancer and persistent hypercalcemia after recent bisphosphonate treatment. The primary endpoint was the proportion of patients with a response, defined as albumin-corrected serum calcium (CSC) <11.5 mg dl within 10 days after the first dose of xgeva.>

Secondary endpoints included the proportion of patients who experienced a complete response (defined as CSC <10.8 mg dl 2.7 mmol l by day 10 time to response and response duration defined as the number of days from the first occurrence of csc><11.5 mg dl. the study achieved its primary endpoint with a response rate at day 10 of 63.6 percent in the 33 patients evaluated. the overall complete response rate was 63.6 percent. the estimated median time to response csc><11.5 mg dl was nine days and the median duration of response was 104 days. the most common adverse reactions in patients receiving xgeva for hypercalcemia of malignancy were nausea dyspnea decreased appetite headache peripheral edema vomiting anemia constipation and diarrhea.>