Pharmaceutical Business review

FDA approves Bayer radium-223 chloride expanded access program

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.