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

 
• By Sue Sutter

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.

Aveo Pharmaceuticals Inc. will face the challenge of convincing FDA’s Oncologic Drugs Advisory Committee that its oral tyrosine kinase inhibitor tivozanib warrants approval for advanced renal cell carcinoma despite an unfavorable survival trend in the pivotal study.

In a notice posted on Feb. 26, FDA announced that ODAC would review tivozanib (proposed trade name Tivopath) during the...

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