Aveo seeks approval of tivozanib for RCC

Aveo Pharmaceuticals Inc. (NASDAQ:AVEO) submitted an NDA to FDA for tivozanib to treat advanced renal cell carcinoma (RCC). The NDA is based on data from the Phase III TIVO-1 trial, which showed that tivozanib met the primary endpoint of median progression-free survival (PFS) vs. sorafenib (11.9 vs. 9.1 months; p=0.042). The application also includes survival analyses that Aveo thinks will address FDA's concerns disclosed last month about the trial's overall survival (OS) trend. Aveo would not disclose the specific analyses but said it will present the data at a medical conference in February. FDA was concerned about an estimated one-year survival rate of 77% in the tivozanib arm compared to 81% in the sorafenib arm; however, the OS data were not yet mature at the time (see BioCentury, Aug. 2). ...