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Approval Or New Study? That’s The Question For Tivozanib Panel Review

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s Oncologic Drugs Advisory Committee is being asked whether Aveo’s renal cell cancer drug should be approved despite an unfavorable overall survival trend in the sole pivotal study; Aveo attributes the survival results to the trial’s one-way crossover design and large proportion of patients from Central/Eastern Europe.

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Tivozanib Communications Come Back To Haunt Aveo, Former Execs

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Aveo’s Tivozanib Will Face Challenging Survival Data At ODAC Review

FDA’s Oncologic Drugs Advisory Committee will consider the tyrosine kinase inhibitor for advanced renal cell carcinoma at a May 2 meeting. Aveo has attributed a negative overall survival trend in the TIVO-1 study to a crossover design and use of post-progression therapies among patients randomized to the comparator arm.


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