Complete Response Letter for Tivozanib New Drug Application in Renal Cell Carcinoma

TOKYO, Japan, June 11, 2013 -Astellas Pharma Inc. (TSE: 4503) today announced that AVEO 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). Complete Response Letter for Tivozanib New Drug Application in Renal Cell Carcinoma (pdf 28 KB) Contact the Media Relations team Communications & Investor Relations Main phone line for Media: ＋81-3244-3201 Business hours (JST) From Monday to Thursday: 8:45 am to 5:45 pm, Friday: 8:45 am to 4:00 pm (closed on Saturdays, Sundays, national holidays and company holidays)

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