(ChemotherapyAdvisor) – XGeva (denosumab) has been denied the expanded indication to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases, according to a press release from Amgen Corporation, Thousand Oaks, CA. Denosumab, a unique, first-in-class RANK Ligand inhibitor, has already been approved by the FDA for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors, including prostate cancer.

On April 26, 2012, the Company received a Complete Response Letter from the US Food and Drug Administration (FDA) that denied approval of the supplemental Biologics License Application (sBLA) for denosumab. According to Amgen’s press release, the Complete Response Letter stated that the FDA cannot approve the application in its present form. The FDA determined that the effect on bone metastases-free survival (BMFS) was of insufficient magnitude to outweigh the risks (including osteonecrosis of the jaw) of denosumab in the intended population, and requested data from an adequate and well-controlled trial(s) that demonstrates a favorable risk-benefit profile for denosumab that is generalizable to the US population, the Company wrote.

“We are reviewing the complete response letter and will work with FDA to determine any next steps,” said Sean E. Harper, MD, Executive Vice President of Research and Development for Amgen. “The FDA’s action does not impact the approved indication of Xgeva in the prevention of skeletal-related events in men with bone metastases from prostate cancer, which was acknowledged by the FDA and the advisory committee members who discussed the application.”  

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