FDA approves Bayer radium-223 chloride expanded access program
Bayer HealthCare has received the US Food and Drug Administration approval to proceed with its expanded access program for the investigational drug radium-223 chloride.
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 is the investigational drug developed for patients diagnosed with castration-resistant prostate cancer (CRPC)/hormone-refractory prostate cancer (HRPC) with symptomatic bone metastases.
Radium-223 chloride will be made available to patients through qualified clinical sites participating in this program, the company said.
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