AVEO Oncology (AVEO) said it has received a Complete Response letter from the U.S. Food and Drug Administration or FDA saying that it would not approve in its present form the New Drug Application or NDA for AVEO's investigational agent tivozanib for the treatment of patients with advanced renal cell carcinoma or RCC.
The FDA, in the letter, said the inconsistent progression-free survival and overall survival results and imbalance in post-study treatments make the TIVO-1 results uninterpretable and inconclusive when making a risk-benefit assessment necessary for drug approval, and urged that AVEO conduct an additional trial to support approval of tivozanib for advanced RCC treatment. Also, the FDA noted that the proposed dissolution acceptance criterion was not supported by the provided dissolution data, and would need to be updated and resubmitted.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.