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FDA Grants Fast Track Designation to Radium-223 Chloride for the Treatment of Castration-Resistant Prostate Cancer That Has Spread to the Bone

Decision may make new treatment available for patients faster

August 23, 2011 -- On June 6, PCF reported on the promising Phase III clinical trial results for radium-223—Alpharadin. (It was presented at the annual American Society of Clinical Oncology meeting in Chicago.) The data showed the compound significantly improves overall survival in patients with castration-resistant prostate cancer that has metastasized to the bone.

Today, Bayer HealthCare Pharmaceuticals announced that radium-223 chloride, exclusively licensed from Algeta ASA, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of castration-resistant (hormone-refractory) prostate cancer in patients with bone metastases.

Radium-223 chloride is an investigational pharmaceutical containing an alpha-particle emitting nuclide in development for cancer patients with bone metastases. In September 2009, Bayer signed an agreement with Algeta ASA (Oslo, Norway) for the development and commercialization of radium-223 chloride. Under the terms of the agreement, Bayer will develop, apply for global health authority approvals, and commercialize radium-223 chloride globally. Radium-223 chloride is an investigational agent and is not approved by the FDA, the European Medicines Agency (EMA) or other Health Authorities.

"We are pleased that the FDA has granted Fast Track designation to radium-223 chloride," said Kemal Malik, MD, Head of Global Development and member of the Bayer HealthCare Executive Committee. "This is an important milestone in the overall development of this compound."

At this year’s upcoming PCF Scientific Retreat, Oliver Sartor, MD, Medical Director of the Tulane Cancer Center, will be giving a talk on Alpharadin.

Fast Track Designation in the United States
Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need. Fast Track addresses a broad range of serious diseases. Fast Track designation must be requested by the drug company and can be initiated at any time during the drug development process. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

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