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AVEO’s Fotivda: US FDA Concerns About Overall Survival Put To Rest By TIVO-3 Final Analysis

 
• By Sue Sutter

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.

Drug Review Profile: Fotivda
AVEO's Fotivda made it to the US market only after the FDA resolved lingering concerns about the drug's impact on overall survival.

Questions about the impact of AVEO Pharmaceuticals, Inc.'s Fotivda (tivozanib) on overall survival in renal cell carcinoma continued to plague the kinase inhibitor in its second Phase III study and threatened to once again derail the drug’s regulatory path to market in the US.

After repeatedly advising AVEO not to submit for approval on the basis of interim overall survival data from TIVO-3 that suggested a negative trend, the US Food and Drug Administration ultimately concluded the final survival analysis did not suggest tivozanib had a detrimental effect, even though median overall survival

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