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AVEO, Astellas Announce FDA Acceptance of NDA Filing for Tivozanib

AVEO Oncology (NASDAQ: 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

Posted-In: News Guidance Financing Contracts Global

 

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