Drug maker seeks new indication: prevention of bone metastasis in men with PCa

Amgen has submitted a supplemental Biologics License Application (sBLA) to the FDA to expand the indication for its RANK ligand inhibitor denosumab (XGEVA) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases.

If approved, denosumab would be the first therapy licensed to prevent or delay the spread of cancer to the bone.

The sBLA 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."