NDA submitted for new advanced RCC agent

October 3, 2012

AVEO Oncology has submitted a new drug application to the FDA seeking approval for tivozanib in patients with advanced renal cell carcinoma.

AVEO Oncology has submitted a new drug application to the FDA seeking approval for tivozanib in patients with advanced renal cell carcinoma.

Tivozanib is designed to target the vascular endothelial growth factor 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 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 versus sorafenib (Nexavar) and a favorable tolerability profile, according to a statement from AVEO and Astellas Pharma Inc., which entered into an agreement last year to develop and commercialize tivozanib in the U.S. and elsewhere. Results from the study were first presented at the American Society of Clinical Oncology 2012 annual meeting in Chicago.

This week, researchers presented additional data on the safety and tolerability profile of tivozanib at the European Society for Medical Oncology 2012 congress in Vienna, Austria. The new, phase III TIVO-1 trial results showed that patients treated with tivozanib experienced fewer grade 3 and off-target adverse events, stayed on treatment longer, and required fewer dose reductions and interruptions compared with those treated with sorafenib, researchers reported in separate presentations.

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