FDA Issues Complete Response Letter to sBLA for Xgeva

Amgen announced that it received a complete response letter from the FDA for it supplemental Biologics License Application (sBLA) for Xgeva (denosumab) injection for the treatment of men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases.

The FDA declined to approve the application because it was determined that the effect on bone metastases-free survival (BMFS) was of insufficient magnitude to outweigh the risks (including osteonecrosis of the jaw) of Xgeva in the intended population.

Xgeva, a RANK ligand inhibitor, is currently approved for the prevention of skeletal-related events (SRE) in patients with bone metastases from solid tumors.

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