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Bayer initiates expanded access program for radium-223 chloride

Monday, February 6, 2012 02:11 PM

The FDA has approved of Bayer Healthcare proceeding with its expanded access program to provide the investigational drug radium-223 chloride to patients diagnosed with castration-resistant prostate cancer (CRPC) and hormone-refractory prostate cancer (HRPC) with symptomatic bone metastases.

Expanded access refers to the use of an investigational drug, under certain circumstances, to treat patients with a serious disease or condition who cannot participate in a controlled clinical trial.

Radium-223 chloride, which is not approved by the FDA, European Medicines Agency or any other health authorities, will be made available to patients through qualified clinical sites participating in this program.

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