AVEO, Astellas Announce FDA Acceptance of NDA Filing for Tivozanib

AVEO Oncology AVEO and Astellas Pharma today announced that the U.S. Food and Drug Administration (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 an investigational medicine and is not currently approved in any country. According to the timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the NDA is expected to be complete by July 28, 2013. 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 See full press release