New Drug Application for Tivozanib for the Treatment of Advanced Renal Cell Carcinoma

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AVEO Oncology and Astellas Pharma, Inc, recently announced that AVEO has submitted a New Drug Application (NDA) to the FDA for tivozanib, in patients with advanced renal cell carcinoma (RCC). 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. The drug is an oral, once-daily, investigational tyrosine kinase inhibitor.

Phase III Trial

The NDA submission is based on results of the global phase III TIVO-1 trial, a randomized superiority-designed pivotal trial evaluating the efficacy and safety of tivozanib compared to sorafenib (Nexavar) 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 the TIVO-1 investigation, tivozanib demonstrated a statistically significant improvement in progression-free survival vs sorafenib, an approved targeted agent, and a favorable tolerability profile.

Results from the study were first presented at the 2012 ASCO Annual Meeting in Chicago.

Tivozanib is also under evaluation across a broad range of solid tumors, including metastatic colorectal cancer and metastatic breast cancer. ■