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Bayer receives approval to begin expanded access program for investigational prostate cancer therapy

Saturday, February 04 2012 | Comments
Evidence Grade 0 What's This?
The Food and Drug Administration agreed to allow Bayer HealthCare LLC to proceed with the company's expanded access program to provide the investigational drug radium-223 chloride to patients with castration-resistant prostate cancer/hormone-refractory prostate cancer with symptomatic bone metastases.

An expanded access program permits, under certain circumstances, the use of an investigational drug in patients with a serious disease or condition who cannot participate in a controlled clinical trial of the drug.

Radium-223 chloride will now be made available to patients through qualified clinical sites that participate in the expanded access program.

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