FDA to review Xgeva(Amgen) potential to delay bone metastases in non-metastatic Prostate Cancer

The FDA has invited Amgen to participate in a meeting of the Oncologic Drugs Advisory Committee (ODAC) on Feb. 8, 2012 to discuss the supplemental Biologics License Application (sBLA) for Xgeva (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases. The review results from clinical studies in support of this new indication, including the pivotal '147 trial, a randomized, placebo-controlled, multi-center Phase III study that compared Xgeva to placebo in prolonging bone metastasis-free survival in men with non-metastatic CRPC who were at high risk for bone metastases based on prostate specific antigen criteria.