AVEO and Astellas Announce Submission of New Drug Application for Tivozanib for the Treatment of Advanced Renal Cell Carcinoma

CAMBRIDGE, Mass. and TOKYO, Japan, September 28, 2012 -- AVEO Oncology (NASDAQ: AVEO) and Astellas Pharma Inc. (TSE: 4503) today announced that AVEO has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for tivozanib in patients with advanced renal cell carcinoma (RCC). Tivozanib is designed to target the vascular endothelial growth factor (VEGF) pathway, a clinically validated target in RCC and other solid tumors. The NDA submission is based on results of the global Phase 3 TIVO-1 (Tivozanib Versus Sorafenib in 1st line Advanced RCC) trial, a randomized superiority-designed pivotal trial evaluating the efficacy and safety of tivozanib compared to sorafenib in 517 patients with advanced RCC who had no prior treatment with a systemic therapy, as well as data from 17 clinical studies involving over 1,000 subjects who received tivozanib. In TIVO-1, tivozanib demonstrated a statistically significant improvement in progression-free survival (PFS) versus sorafenib, an approved targeted agent, and a favorable tolerability profile. Results from the study were first presented in early June 2012 at the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting in Chicago, IL. AVEO and Astellas Announce Submission of New Drug Application for Tivozanib for the Treatment of Advanced Renal Cell Carcinoma (pdf 49 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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