The FDA has assigned the application standard review and a Prescription Drug User Fee Act target action date of March 31, 2021. The FDA also indicated that they do not currently plan on convening an Oncologic Drug Advisory Committee (ODAC) to discuss the application.
“The acceptance of our NDA filing marks yet another important milestone for AVEO, as we pursue our goal of providing RCC patients whose disease has relapsed or become refractory to multiple lines of therapy with a meaningful new treatment option,” said Michael Bailey, president and chief executive officer. “We look forward to working closely with the FDA over the coming months during their review of our application. In parallel, we continue to focus on commercial-readiness to ensure we are well positioned to support the potential launch of tivozanib, subject to approval.”
The NDA submission is based on AVEO’s pivotal Phase 3 study, TIVO-3, comparing tivozanib to sorafenib in 3rd and 4th line RCC, including results recently presented at the American Society of Clinical Oncology 2020 Virtual Scientific Program. The application is also supported by three additional trials, including an active comparator-controlled Phase 3 study, TIVO-1, comparing tivozanib to sorafenib in first line RCC, and two Phase 2 studies, Study 902, the open-label, crossover clinical study of tivozanib for patients who progressed on sorafenib in TIVO-1, as well as placebo-controlled Study 201 in first line RCC. In total, data from over 1,000 clinical trial subjects support the application.
Source: Company Press Release