Aveo’s Tivozanib Falls On Survival Data, Study Design Flaws
This article was originally published in The Pink Sheet Daily
In a lopsided vote, FDA’s Oncologic Drugs Advisory Committee said the renal cell carcinoma drug has not been shown to have a favorable benefit/risk profile due to a negative trend in overall survival and flaws in the design and conduct of the sole pivotal trial.
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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.
In the Phase III TIVO-3 study, tivozanib is associated with a trend toward adverse survival and trial has missing data issues.
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