FDAnews Drug Daily Bulletin

Aveo Gets More Disappointing Results for Tivozanib

Dec. 16, 2013

Interim analysis of a Phase II open-label, randomized study of tivozanib as part of a combination therapy in colorectal cancer patients showed the trial is unlikely to meet its primary endpoint of superiority to a bevacizumab-based therapy, Aveo Oncology said Friday.

The BATON-CRC study, led by partner Astellas, was prompted by a June complete response letter, in which the FDA rejected tivozanib for a kidney cancer indication and asked for a new application pursuant to further studies. Aveo instead abandoned the drug for kidney cancer to concentrate on Phase II studies of breast and colorectal cancers.

Aveo and Astellas said they continue to analyze the BATON-CRC data and will decide follow-up steps at a later date. — Lena Freund

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