AVEO Oncology (NASDAQ: AVEO) and Astellas Pharma Global Development, Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the company's New Drug Application (NDA) for tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC) during the morning session of its meeting on May 2, 2013. ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer, and makes recommendations to the Commissioner of Food and Drugs. 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.
In November 2012, AVEO and Astellas announced that the FDA accepted for filing the NDA for tivozanib with the proposed indication for the treatment of patients with advanced RCC. The NDA includes results of the global Phase 3 TIVO-1 ( TIvozanib Versus s Orafenib in 1 st 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, as well as data from 16 additional AVEO-sponsored studies involving over 1,000 subjects who received tivozanib. Tivozanib is an investigational medicine and is not currently approved in any country.
Tivozanib is an oral, once-daily, investigational tyrosine kinase inhibitor for which positive results from a Phase 3 clinical study in advanced RCC have been reported, and is being evaluated in other tumors.About Kidney Cancer Advanced RCC, or kidney cancer, is the ninth most commonly diagnosed cancer in men and women in the U.S. 1 Worldwide it is estimated that more than 250,000 people are diagnosed and more than 100,000 people die from the disease each year. 2 RCC accounts for more than 90 percent of all kidney cancers. 3 About the AVEO/Astellas Collaboration In February 2011, AVEO and Astellas entered into a worldwide agreement to develop and commercialize tivozanib outside of Asia for the treatment of a broad range of cancers. Subject to regulatory approval, AVEO will lead commercialization of tivozanib in North America and Astellas will lead commercialization of tivozanib in the European Union (EU).