Amgen Invited for ODAC Meeting to Discuss XGEVA sBLA

Amgen plans to discuss the proposed sBLA with ODAC, to support the use of XGEVA in the treatment of men with non-metastatic CRPC.

The U.S. 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 ODAC will review results from clinical studies in support of this new indication, including the pivotal '147 trial, a randomized, placebo-controlled, multi-center Phase 3 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. 

Amgen plans to discuss the proposed sBLA with ODAC, to support the use of XGEVA in the tre