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BioPharmaceutical United States Advisory Committees

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

This article was originally published in The Pink Sheet Daily

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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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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