FDA grants fast-track designation to Bayer’s radiation drug for prostrate cancer
Earlier on Tuesday, Bayer HealthCare Pharmaceuticals announced that an investigational drug involving targeted radiation for prostate cancer treatment has been granted fast-track designation by the US regulatory agency.
A clinical trial conducted by Bayer for the investigational drug radium-223 chloride, which is exclusively licensed from Algeta ASA, involves the tumor treatment through targeted radioactive particles. The drug is being studied for castration-resistant (hormone-refractory) prostate cancer patients with bone metastases. The investigational drug is still in the review stage, and has not been approved by the FDA, the European Medicines Agency (EMA), or other Health Authorities.
The FDA’s verdict will facilitate systematic submission of the marketing application by Bayer rather than a complete dossier submission at once. The FDA may use its discretion to conduct a 6-months review instead of a standard 10-month review of application.
Head of Global Development and member of the Bayer HealthCare Executive Committee, Kemal Malik, MD, said: “We are pleased that the FDA has granted Fast Track designation to radium-223 chloride. This is an important milestone in the overall development of this compound.”
Bayer halted a late-stage clinical trial of radium-223 chloride in June as the drug achieved its primary study end point. Compared to a median survival time of 11.2 months in patients who took a placebo, a median survival time of 14 months was observed in those who were administered the drug. Prostrate cancer patients in the placebo group were presented with an opportunity to move to the radium-223 chloride treatment group at the end of the trial.
Bayer HealthCare Pharmaceuticals is the US subsidiary of Bayer AG, a German health care company.