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FDA to Review Potential New Use of XGEVA® (Denosumab) at Oncologic Drugs Advisory Committee Meeting
Date:12/29/2011

THOUSAND OAKS, Calif., Dec. 29, 2011 /PRNewswire/ -- 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.).

About XGEVA

XGEVA is the first and only RANK Ligand inhibitor approved by the FDA indicated for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. XGEVA was initially approved following a six month priority review by the FDA.  XGEVA is not indicated for the prevention of SREs in patients with multiple myeloma. XGEVA is the first novel bone metastases treatment for advanced cancer patients in nearly a decade. Delivered as an every four week 120 mg subcutaneous injection, XGEVA provides a unique option for urol
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SOURCE Amgen
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