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...