Posted by Michael Wonder on 02 Jun 2020
AVEO Oncology announces FDA acceptance for filing of a new drug application for tivozanib as a treatment of relapsed or refractory renal cell carcinoma
1 June 2020 - Tivozanib assigned PDUFA target action date of 31 March 2021; FDA indicates that it does not currently plan to convene an ODAC.
AVEO Oncology today announced that the U.S. FDA accepted for filing its new drug application seeking approval for tivozanib, the Company’s next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor, as a treatment for relapsed or refractory renal cell carcinoma (RCC).
The submission is based on AVEO’s pivotal Phase 3 study, TIVO-3, comparing tivozanib to sorafenib in third and fourth line RCC, including results recently presented at the American Society of Clinical Oncology 2020 Virtual Scientific Program.
