Monday, June 10, 2013
FDA rejects Aveo kidney cancer drug, asks for additional trial
A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012.
Credit: Reuters/Jason Reed
(Reuters) - Aveo Oncology said the Food and Drug Administration denied approval for its experimental kidney cancer drug citing inconsistent trial results and asked for an additional study.
In a complete response letter to the company, the health regulator said inconsistent survival data from the drug tivozanib's trials made the results "uninterpretable and inconclusive.
(Reporting by Esha Dey in Bangalore)
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