AVEO Oncology (AVEO: Quote) Friday announced that the company, along with Astellas Pharma Inc., has submitted a New Drug Application or the NDA to the U.S Food and Drug Administration, or the FDA, seeking approval for tivozanib in patients with advanced renal cell carcinoma. or RCC.
The cancer therapeutics company stated that Tivozanib is designed to target the vascular endothelial growth factor (VEGF) pathway, a clinically validated target in RCC and other solid tumors.
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.
The company further added that the NDA submission is based on results of the global Phase 3 TIVO-1 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
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by RTT Staff Writer
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