Posted by Michael Wonder on 01 Apr 2020
Aveo Oncology announces submission of new drug application to U.S. FDA for tivozanib in patients with relapsed or refractory renal cell carcinoma
31 March 2020 - Aveo Oncology today announced that it has submitted a new drug application to the U.S. FDA for tivozanib, the Company’s vascular endothelial growth factor receptor tyrosine kinase inhibitor, as a treatment for relapsed or refractory renal cell carcinoma.
The submission is based on the pivotal active comparator-controlled Phase 3 study, TIVO-3, comparing tivozanib to sorafenib in third and fourth-line renal cell carcinoma (RCC) patients. The application is supported by three additional trials, including an active comparator-controlled supportive Phase 3 study, TIVO-1, comparing tivozanib to sorafenib, and two Phase 2 studies, Study 902, the open-label, cross-over clinical study of tivozanib for patients who progressed on sorafenib in TIVO-1, as well as placebo-controlled Study 201 in first-line RCC patients.
