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.
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