Tivozanib “Complete Response” Shows Increased Communications Can’t Always Save An NDA
This article was originally published in The Pink Sheet Daily
Aveo got extensive advice from FDA, but bad data and its decision not to conduct an additional trial led to a rejection for its kidney cancer application.
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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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