FDA clears Bayer's Xofigo

The U.S. Food and Drug Administration (FDA) has cleared the use of radium-223 dichloride to treat patients who have castration-resistant prostate cancer (CRPC) with symptomatic bone metastases and no known visceral metastatic disease.

Bayer HealthCare has worldwide exclusive marketing rights for radium-223 dichloride under the brand name Xofigo. Algeta and Bayer HealthCare will jointly promote the product in the U.S.

According to Bayer, commercial production of Xofigo is underway and first doses are expected to be ready for patient treatment within a few weeks. Radium-223 dichloride has a short range of penetration of alpha particles, sparing nearby healthy tissues and essential bone marrow.

In clinical trials, radium-223 dichloride showed improvement in overall survival and a delay in time to first symptomatic skeletal event compared to placebo.

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