Approval Or New Study? That’s The Question For Tivozanib Panel Review
This article was originally published in The Pink Sheet Daily
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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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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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.