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

Get Permission

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. ■




By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.