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Amgen Says FDA To Target PDUFA Date Of Apr. 26, 2012 For XGEVA SBLA -Quick Facts

Amgen Inc. (AMGN) said the U.S. Food and Drug Administration will target a Prescription Drug User Fee Act action date of April 26, 2012 for the supplemental Biologics License Application to expand the indication for XGEVA to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases.

If approved in this expanded indication, XGEVA, or denosumab, would become the first therapy licensed to prevent or delay the spread of cancer to bone.

XGEVA is the first and only RANK Ligand inhibitor approved by the FDA indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors.

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