Amgen has submitted a supplemental Biologics License Application to FDA to expand the indication for Xgeva to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases, according to a company press release.
Amgen has submitted a supplemental Biologics License Application (sBLA) to FDA to expand the indication for Xgeva (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases, according to a company press release. Xgeva currently is approved in the United States for the prevention of skeletal-related events in patients with bone metastases from solid tumors.
The sBLA submission is based on a pivotal phase 3 study ('147), which evaluated Xgeva versus placebo in 1,432 men with castrate-resistant prostate cancer. The study results demonstrated that Xgeva 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.
Adverse events and serious adverse events were relatively similar between both the Xgeva group and the placebo group. Back pain was the most common adverse event reported in the Xgeva arm. Hypocalcemia and osteonecrosis of the jaw (ONJ) were reported with increased frequencies in patients treated with Xgeva; however the yearly rate of ONJ in the Xgeva arm was similar to prior trial results.
"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, executive vice president of research and development at Amgen, in the press release. "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."