AVEO Oncology (NASDAQ:AVEO) has announced that the US FDA has approved FOTIVDA® (tivozanib) for treating refractory/relapsed advanced renal cell carcinoma adults that have previously received two or more systemic therapies. FOTIVDA is a next-generation oral vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).
FOTIVDA offers a new treatment alternative for RCC patients
Brian Rini, TIVO-3 trial principal investigator, said that the FOTIVDA approval offers a new tool for treating kidney cancer patients that have become refractory or relapsed from two or more previous systemic therapies. He said that with RCC treatment advances, patients live longer, thus enhancing the end for proven, well-tolerated treatment alternatives in the refractory or relapsed setting. Brian said that the TIVO-3 trial is the first third phase RCC study to incorporate a predefined patient population previously received immunotherapy. The approval reflects an attractive intervention or FOTIVDA, and it will play a vital role in the growing RCC treatment landscape.
AVEO CEO and President Michael Bailey said that they are optimistic about FOTIVDA’s potential to offer a differentiated treatment alternative for the rapidly increasing patients number with refractory or relapsed RCC in the US. Bailey said that the approval marks the culmination of years of determination and hard work to bring the therapy to patients. Most importantly, the approval commences AVEO’s journey as a commercial-stage company which is a huge accomplishment.
AVEO to avail FOTIVDA end of March
KCCure president Dena Battle said that refractory or relapsed RCC is a devasting disease, limiting patient outcomes because of the tradeoff between efficacy and tolerability. Therefore the FDA approval represents a meaningful advancement in providing a new treatment alternative for the patient population.
AVEO will avail FOTIVDA to patients in the US by March 31, 2021. The pivotal phase 3, TIVO-3 study results comparing FOTIVDA to sorafenib in treating r/r advanced RCC after previous systemic therapies supported the FDA approval. Also, three additional RCC trials, including safety data from more than 1000 subjects, supported the application.