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%. 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.
“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,” said William Slichenmyer, M.D., Sc.M., chief medical officer at AVEO.
“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 Stephen Eck, M.D., Ph.D., vice president of medical oncology, Astellas Pharma Global Development.AVEO Conference Call and Webcast These data will be reviewed in more detail by AVEO management during the company’s conference call and webcast tomorrow at 10:00 a.m. (ET). The call can be accessed by dialing 1-866-831-6243 (domestic) or 1-617-213-8855 (international) five minutes prior to the start of the call and providing the passcode 81400823. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-888-286-8010 (domestic) or 1-617-801-6888 (international), providing the passcode 61126312. The replay will be available for two weeks from the date of the call.