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

 
• By Sue Sutter

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.

At the FDA Oncologic Drugs Advisory Committee’s May 2 meeting, Aveo Pharmaceuticals Inc. will have to make its case for approval of the renal cell carcinoma drug tivozanib despite failing to heed the agency’s advice to conduct a second pivotal study due to a negative survival trend in the sole Phase III trial.

ODAC is being asked to vote on whether another trial is needed to better characterize tivozanib’s risk/benefit profile before approval...

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