From Earlier: FDA to Review Potential New Use of XGEVA at Oncologic Drugs Advisory Committee Meeting

Amgen

yesterday announced the U.S. Food and Drug Administration has invited the Company to participate in a meeting of the Oncologic Drugs Advisory Committee on Feb. 8, 2012 to discuss the supplemental Biologics License Application for XGEVA® (denosumab) to treat men with castration-resistant prostate cancer 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.