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).