AVEO Pharmaceuticals Inc. (AVEO), doing business as AVEO Oncology, said Thursday a committee of the U.S. Food and Drug Administration rejected its investigational agent tivozanib to treat advanced renal cell carcinoma as the drug failed to show a favorable benefit-to-risk evaluation in affected patients.
Shares of Aveo, which were initially halted pending the FDA panel decision, tumbled about 50 percent at the close of markets.
The FDA's Oncologic Drugs Advisory Committee voted 13 to 1, in deciding to reject the drug. While the FDA is not bound by the committee's decision, it usually considers it. A final decision on the drug is expected by July 28.
The Committee's decision was based on findings from a total of 17 trials involving more than 1,000 patients.
Advanced renal cell carcinoma (RCC), or kidney cancer, is the ninth most commonly diagnosed cancer in men and women in the U.S. Globally, it is estimated that more than 250,000 people are diagnosed and more than 100,000 people die from the disease each year.
Tivozanib is an oral, once-daily, investigational vascular endothelial growth factor(VEGF) tyrosine kinase inhibitor, and is being evaluated in other tumors as well.
In February 2011, Cambridge, Massachusetts-based AVEO and Astellas Pharma Inc. (ALPMY.PK) agreed develop and commercialize tivozanib outside of Asia for the treatment of a broad range of cancers. Subject to regulatory approval, AVEO will lead commercialization of tivozanib in North America and Astellas will lead commercialization of tivozanib in the European Union.
AVEO closed Thursday at $2.65, down 49.62%, on a volume of 15.2 million shares on the
Nasdaq. In after hours, the stock gained $0.04 or 1.51%.
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