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Tivozanib is an oral, once-daily, investigational tyrosine kinase inhibitor for which positive results from a Phase 3 clinical study in advanced renal cell carcinoma (RCC, a type of kidney cancer) have been reported and is being evaluated in other tumors. AVEO has submitted a New Drug Application (NDA) for review by the FDA.
On May 2, 2013, an FDA panel of experts discussed the efficacy and safety of tivozanib and voted against recommending approval. The committee voted 13 to 1 against tivozanib, deciding that AVEO Oncology had not produced the required efficacy data. The FDA review is expected to be complete by July 28, 2013.
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