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FDA Agrees to Review Tivozanib for Advanced Renal Cell Carcinoma

Agency decision expected in July 2013 (Nov. 28)

The FDA has accepted for filing the New Drug Application (NDA) for tivozanib (Aveo Oncology) with a proposed indication for the treatment of patients with advanced renal cell carcinoma (RCC). Tivozanib is an investigational compound and is not currently approved in any country. Review of the NDA is expected to be complete by July 28, 2013. The NDA includes results of the phase III TIVO-1 (TIvozanib Versus SOrafenib in 1st-line Advanced RCC) trial –– a randomized pivotal study evaluating the efficacy and safety of tivozanib compared with sorafenib in 517 patients with advanced RCC –– as well as data from 16 additional studies involving more than 1,000 subjects who received tivozanib. The results of the TIVO-1 trial were presented at the 2012 Annual Meeting of the American Society for Clinical Oncology (ASCO).

The proposed brand name for tivozanib is Tivopath. Tivozanib is an investigational once-daily tyrosine kinase inhibitor. Its safety and efficacy have not yet been fully established.

Advanced RCC 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 with RCC and that more than 100,000 people die from the disease each year. RCC accounts for more than 90% of all kidney cancers. Currently available therapies provide less than 1 year of median progression-free survival in treatment-naïve patients and are associated with significant toxicities.

Source: Aveo Oncology; November 28, 2012.

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