NDA Filing for Tivozanib for Advanced Renal Cell Carcinoma Accepted

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AVEO and Astellas announced that the FDA has accepted for filing the New Drug Application (NDA) for tivozanib with the proposed indication for the treatment of patients with advanced renal cell carcinoma (RCC). Tivozanib is a potent, selective, long half-life inhibitor of all three vascular endothelial growth factor (VEGF) receptors that is designed to optimize VEGF blockade while minimizing off target toxicities.

The NDA includes 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 (Nexavar; Bayer and Onyx) in 517 patients with advanced RCC, as well as data from 16 additional AVEO-sponsored studies involving over 1,000 subjects who received tivozanib.

For more information call (617) 299-5000 or visit www.aveopharma.com.

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