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