Amgen (NASDAQ: AMGN) today announced the U.S. Food and Drug Administration (FDA) has invited the Company 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 treatment of men with non-metastatic CRPC; a patient population for whom there are no approved treatments to delay or prevent the spread of cancer to bone.
The sBLA was submitted on June 27, 2011, and a Prescription Drug User Fee Act action date has been scheduled for April 26, 2012. If approved, this will be the second indication for XGEVA in the United States (U.S.).