Brian I. Rini, MD
Although the VEGF TKI tivozanib (Fotivda) demonstrated superior progression-free survival (PFS) and tolerability compared with sunitinib (Sutent) in the TIVO-3 study, its role remains unclear following the FDA’s recommendation to not submit a new drug application (NDA) of tivozanib for patients with highly refractory, advanced or metastatic renal cell carcinoma (RCC).
In January 2019, the FDA stated that Aveo Oncology, the developer of tivozanib, should not submit the NDA following the preliminary overall survival (OS) findings from the phase III TIVO-3 trial in this patient population, adding that the data do not alleviate their concerns regarding a potential detriment in OS, which were outlined in a complete response letter issued in June 2013.1
Aveo Oncology previously stated that it plans to make an NDA filing decision following the availability of additional mature OS results.
... to read the full story