sBLA Submitted for Xgeva for Expanded Indication

Amgen announced the submission of a supplemental Biologics License Application (sBLA) to the FDA to expand the indication for Xgeva (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. The sBLA submission is based on a pivotal Phase 3 Study ('147) evaluating Xgeva vs. placebo in 1,432 men with castrate-resistant prostate cancer. Results of the '147 study demonstrated that Xgeva significantly prolonged bone metastasis-free survival by more than four months compared with placebo (29.5 vs. 25.2 months, respectively) in men with castrate-resistant prostate cancer that had not yet spread to the bone. If approved, Xgeva would be the first therapy licensed to prevent or delay the spread of cancer to the bone.

Xgeva is a fully human monoclonal antibody that binds to RANK Ligand, a protein essential for the formation, function and survival of osteoclasts. Xgeva prevents RANK Ligand from activating its receptor, RANK, on the surface of osteoclasts, thereby decreasing bone destruction. 

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