(By Balaseshan) AVEO Pharmaceuticals Inc. (NASDAQ: AVEO) and Astellas Pharma Inc. say the U.S. Food and Drug Administration (FDA) has accepted of the New Drug Application (NDA) filing for tivozanib to treat advanced renal cell carcinoma.
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 FDA's acceptance of the NDA triggers a $15 million milestone payment to AVEO under its development and commercialization agreement with Astellas.
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The proposed brand name for tivozanib is Tivopath, which is a trademark of AVEO Pharma. 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.
Advanced renal cell carcinoma (RCC), or kidney cancer, is the ninth most commonly diagnosed cancer in men and women in the U.S. Worldwide it is estimated that more than 250,000 people are diagnosed and more than 100,000 people die from the disease each year. RCC accounts for more than 90% of all kidney cancers.
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 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.
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Results of TIVO-1 were presented at the 2012 Annual Meeting of the American Society for Clinical Oncology (ASCO). Tivozanib is also under evaluation across a broad range of solid tumors, including metastatic colorectal cancer and metastatic breast cancer.
AVEO closed Tuesday's regular session up 0.14% at $7.11. The stock has been trading between $5.80 and $17.65 for the past 52 weeks.