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.
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.
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