Amgen Announces PDUFA Date for XGEVA Supplemental Biologics License Application

Amgen AMGN today announced that the U.S. Food and Drug Administration will target a Prescription Drug User Fee Act action date of April 26, 2012 for the supplemental Biologics License Application to expand the indication for XGEVA® (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. Bone is one of the most common places for cancer to spread. If approved in this expanded indication, XGEVA would become the first therapy licensed to prevent or delay the spread of cancer to bone.