AVEO’s Fotivda: US FDA Concerns About Overall Survival Put To Rest By TIVO-3 Final Analysis
After repeatedly advising against tivozanib NDA submission on the basis of interim overall survival data that suggested a negative trend, agency ultimately concluded the final analysis did not suggest a detrimental effect in third-line renal cell carcinoma even though median overall survival was shorter than for the comparator agent, Bayer’s Nexavar.
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An August 2019 analysis of overall survival in the TIVO-3 study of Aveo’s tivozanib in advanced renal cell carcinoma is now an interim rather than a final analysis, but EU regulators may take action if a negative overall survival trend is found to be continuing.