CAMBRIDGE, Mass. and TOKYO, Japan, May 2, 2013 - AVEO Oncology (NASDAQ: AVEO) and Astellas Pharma Inc. (TSE: 4503) today reported that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted that the application for investigational agent tivozanib did not demonstrate a favorable benefit-to-risk evaluation for the treatment of advanced renal cell carcinoma (RCC) in an adequate and well-controlled trial (13 to 1, 0 abstentions).
“While we are disappointed with the outcome of the ODAC vote, we remain confident in the efficacy, safety and tolerability of tivozanib in RCC patients,” said Tuan Ha-Ngoc, president and chief executive officer of AVEO. “We are committed to the RCC patient community and will work closely with the FDA to address the issues discussed by the panel today as the Agency continues its ongoing review of the New Drug Application for tivozanib.”
The ODAC provides the FDA with independent expert advice and recommendations. The FDA is not bound by the Committee's guidance, but its input will be considered by the Agency in its review of the tivozanib New Drug Application (NDA), which was submitted by AVEO on September 28, 2012. 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 ODAC reviewed findings from a total of 17 trials involving more than 1,000 patients, including 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, an approved targeted agent, in 517 patients with advanced RCC. In TIVO-1, tivozanib demonstrated a statistically significant improvement in progression-free survival, the primary endpoint of the study, and a favorable tolerability profile when compared to sorafenib.