The FDA denied the approval of a New Drug Application for tivozanib, which was submitted by its manufacturer (Aveo Pharmaceuticals/Astellas), for the treatment of renal-cell carcinoma. In its Complete Response letter to the company, the FDA noted that the survival results from the TIVO-1 clinical trial were inconsistent, which made the results “uninterpretable and inconclusive.” The FDA requested that the company provide new survival data from new clinical trials. Tivozanib is currently in phase 2 clinical trials for the treatment of colorectal cancer. (June 10, 2013)
