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February 27, 2013
06:34 EDTAVEOAveo Pharmaceuticals' NDA for tivozanib to be reviewed by FDA on May 2
AVEO and Astellas Pharma Global Development, a U.S. subsidiary of Tokyo-based Astellas Pharma, announced that the FDA's Oncologic Drugs Advisory Committee will review the company's New Drug Application for tivozanib for the treatment of patients with advanced renal cell carcinoma during the morning session of its meeting on May 2. ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer, and makes recommendations to the Commissioner of Food and Drugs. The review of the NDA is expected to be complete by July 28. Tivozanib is an investigational medicine and is not currently approved in any country.
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