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Aveo’s Tivozanib Falls On Survival Data, Study Design Flaws

 
• By Sue Sutter

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.

A negative survival trend and design flaws in the lone pivotal trial for Aveo Pharmaceuticals Inc.’s tivozanib outweighed the statistically significant progression-free survival benefit seen with the renal cell carcinoma drug, an FDA advisory committee said May 2.

FDA’s Oncologic Drugs Advisory Committee voted 13-1 that Aveo failed to demonstrate a favorable benefit/risk evaluation for treatment of renal...

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