FDA advisory panel overwhelming recommends rejection of Aveo’s kidney cancer drug

An advisory panel Thursday recommended the Food and Drug Administration reject a kidney cancer drug developed by Aveo Pharmaceuticals Inc., sending the Cambridge biotechnology company’s stock down more than 47 percent to $2.77 a share in afternoon trading.

The 13-1 vote against approving the experimental drug known as tivozanib is a blow to Aveo, which last fall restructured its operations to focus resources on the the treatment. While the vote by a national committee of cancer specialists isn’t binding, the FDA only rarely overrides an advisory panel recommendation. It is set to decide on the drug by July 28.

Despite the overwhelming vote against recommending approval, Aveo executives said they will push forward with the kidney cancer drug.

Continue Reading Below

“While we are disappointed with the outcome of the (panel) vote, we remain confident in the efficacy, safety and tolerability of tivozanib in renal cell carcinoma patients,” Aveo chief executive Tuan Ha-Ngoc said in a statement. “We are committed to the renal cell carcinoma patient community and will work closely with the FDA to address the issues discussed by the panel today as the agency continues its ongoing review of the new drug application for tivozanib.”

Share