FDA approves new prostate cancer drug

Bayer's Xofigo receives approval for metastatic, castration-resistant prostate cancer

SILVER SPRING, Md. — A new treatment for late-stage prostate cancer has received approval from the Food and Drug Administration.

The FDA announced Wednesday the approval of Bayer's Xofigo (radian Ra 223 dichloride) for men with symptomatic, castration-resistant prostate cancer that has spread to the bones but not other organs, also known as metastasis. The drug is designed 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," FDA Office of Hematology and Oncology Products director Richard Pazdur said. "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."

Pazdur was referring to Astellas' and Medivation's Xtandi (enzalutamide), which the agency approved in August 2012 for men with metastatic, castration-resistant prostate cancer that has spread and recurred after medical or surgical therapy after they have been treated with the chemotherapy drug docetaxel.


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