THOUSAND OAKS, Calif. — A drug made by Amgen delayed the spread of prostate cancer to the bones in men with the disease and prolonged the survival of men with the condition, according to results of a late-stage clinical trial.
Published in The Lancet, the phase-3 "147 study" evaluated Xgeva (denosumab) in men with nonmetastatic, castration-resistant prostate cancer, also known as CRPC. The study "significantly prolonged" survival without bone metastasis, delayed time to bone metastasis and reduced the risk of symptomatic bone metastasis. The company has filed a regulatory approval application with the Food and Drug Administration seeking approval for Xgeva to reduce the risk of CRPC spreading to the bones.
"The prevention of bone metastases is a major unmet medical need for men with castration-resistant prostate cancer," Massachusetts General Hospital Cancer Center medical professor Matthew Smith said. "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."