Bayer receives approval to begin expanded access program for investigational prostate cancer therapy
Saturday, February 04 2012 | Comments
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.