Amgen (NASDAQ: AMGN) announced today the publication of results from a Phase 3 trial (the '147 study) that evaluated XGEVA® (denosumab) for use in preventing or delaying the onset of bone metastases in men with nonmetastatic castration-resistant prostate cancer (CRPC). Published in The Lancet
, the study found XGEVA significantly prolonged bone metastasis-free survival, delayed time to bone metastasis and reduced the risk of symptomatic bone metastases. This study is the first to demonstrate that targeting the bone microenvironment prevents bone metastasis in men with prostate cancer.
"The prevention of bone metastases is a major unmet medical need for men with castration-resistant prostate cancer. Bone metastases are a significant concern for these patients who have historically had poor outcomes," Matthew Smith, M.D., Ph.D., professor of medicine and the director of Genitourinary Oncology at Massachusetts General Hospital Cancer Center. "The more than four-month increase in bone metastasis-free survival with XGEVA treatment is a clinically significant finding that has the potential to improve the management of men living with prostate cancer."
Based on the results of this study, Amgen filed a supplemental Biologics License Application (sBLA) to expand the indication for XGEVA to treat men with CRPC to reduce the risk of developing bone metastases. The U.S. Food and Drug Administration (FDA) has set April 26, 2012 as the targeted Prescription Drug User Fee Act (PDUFA) action date for the sBLA. If approved, XGEVA would be the first-and-only therapy licensed to prevent or delay the spread of cancer to the bone.