The FDA has approved Xofigo for treatment of men with late-stage, castration-resistant prostate cancer. The drug will be available to patients whose cancer has spread to the bones but not to other organs, according to the agency.
The treatment uses pinpoint delivery of alpha radiation to combat cancer. Because of its targeted approach, cancer cells are killed off with less damage to surrounding tissue than standard radiation therapies.
Xofigo's safety and efficacy were tested in a clinical trial of 809 men with castration-resistant prostate cancer. The group receiving Xofigo lived a median of 14 months compared to a median of 11.2 months for men receiving placebo.
"Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues," said Richard Pazdur, M.D., for the FDA.
"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."
According to the National Cancer Institute, an estimated 238,590 men will be diagnosed with prostate cancer and 29,720 will die from the disease in 2013.
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