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FDA Approval Sought for Tivozanib for Advanced Kidney Cancer

Drug was more effective than sorafenib in pivotal trial (Sept. 28)

Aveo Oncology, based in Cambridge, Mass., announced on September 28 that it has submitted a new drug application (NDA) to the FDA seeking approval for tivozanib in patients with advanced renal cell carcinoma (RCC). Tivozanib is designed to target the vascular endothelial growth factor (VEGF) pathway, a clinically validated target in RCC and other solid tumors.

The NDA submission is based on results of the global phase III TIVO-1 (Tivozanib Versus Sorafenib in 1st line Advanced RCC) trial, a randomized superiority-designed pivotal trial that evaluated the efficacy and safety of tivozanib compared with that of sorafenib (Nexavar) in 517 patients with advanced RCC who had no prior treatment with a systemic drug, as well as data from 17 clinical studies involving more than1,000 patients who received tivozanib. In TIVO-1, tivozanib demonstrated a statistically significant improvement in progression-free survival (PFS) versus sorafenib and a favorable tolerability profile.

Results from the study were presented in June 2012 at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Ill.

Advanced RCC is the ninth most commonly diagnosed cancer in men and women in the U.S. Worldwide, more than 250,000 people are diagnosed with RCC and more than 100,000 die from the disease each year. RCC accounts for more than 90% of all kidney cancers.

Tivozanib selectively inhibits all three vascular endothelial growth factor (VEGF) receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities.

For more information, visit the Aveo Oncology Web site.

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