Updated on 19 February 2013
In TIVO-1, tivozanib demonstrated a statistically significant improvement in progression-free survival (PFS), the primary endpoint of the study, when compared with sorafenib. The FDA has accepted the tivozanib NDA for filing, and according to the timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the NDA is expected to be complete by July 28, 2013. Other data being presented at ASCO GU show the anti-tumor activity of tivozanib following treatment with sorafenib resulted in a median PFS of 8.4 months and response rate of 13 percent.
These data have matured and have been updated from the initial ASCO GU abstract submission (abstract #364), and will be included in the poster. Additional TIVO-1 data relating to subset analyses (abstracts #354 and #361) and quality of life (abstract #355) will also be included in posters presented at ASCO GU.
Dr William Slichenmyer, chief medical officer, Aveo, said that, "We believe that these data being presented at ASCO GU reinforce the positive efficacy results and safety profile of tivozanib in patients with advanced RCC."
"We are excited to be working with AVEO in our efforts to bring tivozanib to patients who are in need of new therapeutic options," added Dr Stephen Eck, vice president of medical oncology, Astellas Pharma Global Development.