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AVEO Oncology (NASDAQ: AVEO) and Astellas Pharma Inc. (TSE:4503) today announced that AVEO has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (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 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 in 517 patients with advanced RCC who had no prior treatment with a systemic therapy, as well as data from 17 clinical studies involving over 1,000 subjects who received tivozanib. In TIVO-1, tivozanib demonstrated a statistically significant improvement in progression-free survival (PFS) versus sorafenib, an approved targeted agent, and a favorable tolerability profile.
Results from the study were first presented in early June 2012 at the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting in Chicago, IL.
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.
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.