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Astellas Pharma Inc Announces Complete Response Letter for Tivozanib New Drug Application in Renal Cell Carcinoma of Co-Developer AVEO Oncology

Monday, 10 Jun 2013 07:00pm EDT 

Astellas Pharma Inc announced that its co-developer, AVEO Oncology, has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) informing the company that FDA cannot approve the New Drug Application (NDA) in its present form for AVEO’s investigational agent tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC). In February 2011, AVEO and Astellas entered into an agreement to develop and commercialize tivozanib outside of Asia for the treatment of a broad range of cancers. 

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18 Apr 2014