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FDA fast-tracks investigational agent for metastatic prostate cancer

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The FDA has granted the investigational compound radium-223 chloride fast-track designation for the treatment of castration-resistant prostate cancer in men with bone metastases. The compound, which is exclusively licensed from Algeta ASA and owned by Bayer HealthCare Pharmaceuticals, is not approved by the FDA, the European Medicines Agency or other health authorities, according to a press release.

“We are pleased that the FDA has granted fast-track designation to radium-223 chloride,” Kemal Malik, MD, head of global development and member of the Bayer HealthCare executive committee, said in the release “This is an important milestone in the overall development of this compound.”

The compound is an investigational pharmaceutical that contains an alpha-particle emitting nuclide. In September 2009, Bayer signed an agreement with Algeta ASA, based in Oslo, Norway, for the development and commercialization of the compound. Under the terms of the agreement, Bayer will develop, apply for global health authority approvals and commercialize radium-223 chloride globally while Algeta retains an option for up to 50/50 co-promotion and profit-sharing in the United States, according to the release.

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