Amgen has submitted a supplemental Biologics License Application (sBLA) to the FDA to expand the indication for denosumab (XGEVA) its RANK ligand inhibitor to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. Although some doctors have already begun to use Xgeva in men with advanced prostate cancer, it is only approved for the treatment of breast cancer.
If approved, denosumab would be the first therapy licensed to prevent or delay the spread of cancer to the bone in men with castrate-resistant prostate cancer.
The submission is based on a phase III study evaluating denosumab versus placebo in 1,432 men with castrate-resistant prostate cancer. Results of the study demonstrated that denosumab significantly prolonged bone metastasis-free survival by more than 4 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.
“The successful outcome of this study provides clinical evidence supporting the view that tumors activate the RANK ligand pathway to penetrate bone,” said Roger M. Perlmutter, MD, PhD, of Amgen. “XGEVA has the potential to become a significant advance for patients with castrate-resistant prostate cancer who currently have no treatment options to help prevent the spread of cancer to their bones.”
This approval would be another step towards slowing down the prostate cancer process.
Joel T Nowak, M.A., M.S.W.