AVEO Oncology (NASDAQ: AVEO) and Astellas Pharma Inc. (TSE: 4503) 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 S Orafenib 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, as well as data from 16 additional AVEO-sponsored studies involving over 1,000 subjects who received tivozanib. Results of TIVO-1 were presented at the 2012 Annual Meeting of the American Society for Clinical Oncology (ASCO).
The proposed brand name for tivozanib is TIVOPATH™, which is a trademark of AVEO Pharmaceuticals, Inc. This name has received conditional acceptance from the FDA and the European Medicines Agency (EMA), but final approval by the FDA and EMA is pending. Tivozanib is an investigational compound. Its safety and efficacy have not yet been fully established.
The FDA’s acceptance of the NDA triggers a $15 million milestone payment to AVEO under its development and commercialization agreement with Astellas.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 Currently available therapies provide less than one year of median PFS in treatment naive patients and are associated with significant toxicities. 4 These toxicities not only lead to high rates of dose reductions and interruptions (potentially compromising efficacy), but also can impact a patient’s quality of daily living. 5 About Tivozanib Tivozanib is a potent, selective, long half-life inhibitor of all three vascular endothelial growth factor (VEGF) receptors that is designed to optimize VEGF blockade while minimizing off target toxicities. Tivozanib is an oral, once-daily, investigational tyrosine kinase inhibitor for which positive results from a Phase 3 clinical study in advanced renal cell carcinoma have been reported. Tivozanib is also under evaluation across a broad range of solid tumors, including metastatic colorectal cancer and metastatic breast cancer.
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