Aveo’s Tivozanib Troubles Reflect Perils Of Ex-U.S. Studies

Pivotal study for the renal cell carcinoma drug was conducted largely in Central and Eastern Europe, where limited access to second-line targeted therapies does not reflect the U.S. practice. In recommending against approval, FDA’s Oncologic Drugs Advisory Committee questioned the study results’ applicability to the U.S.

The negative FDA Oncologic Drugs Advisory Committee review of Aveo Pharmaceuticals Inc.’s renal cell carcinoma drug tivozanib should serve as a cautionary tale for pharmaceutical companies looking overseas to seed their clinical trials.

Not only must sponsors ensure that clinical trials reflect U.S. standard of care, they also must ensure that post-trial treatments...

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