Bayer’s prostate cancer drug wins early FDA approval

Bayer's new prostate cancer drug has been approved in the US three months ahead of schedule through the FDA's priority review system.

Xofigo (radium Ra 223 dichloride) has been approved to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.

"Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues. Xofigo is the second prostate cancer drug approved by the FDA in the past year that demonstrates an ability to extend the survival of men with metastatic prostate cancer."

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.

Xofigo's safety and effectiveness were evaluated in a single clinical trial of 809 men with symptomatic castration-resistant prostate cancer that spread to bones but not to other organs. Patients were randomly assigned to receive Xofigo or a placebo plus best standard of care. Designed to measure overall survival, data from the study showed men receiving Xofigo lived a median of 14 months compared to a median of 11.2 months for men receiving placebo.

In 2013, an estimated 238,590 men will be diagnosed with prostate cancer and 29,720 will die from the disease, according to the National Cancer Institute.