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Advisory committee votes against tivozanib for RCC
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An FDA advisory panel today rejected tivozanib as a treatment for advanced renal cell carcinoma.
Tivozanib (AVEO Oncology and Astellas Pharma) is an oral, once daily, investigational tyrosine kinase inhibitor of all three VEGF receptors that is designed to optimize VEGF blockade while minimizing off-target toxicities.
The FDA’s Oncologic Drugs Advisory Committee voted 13 to 1 against the manufacturers’ new drug application, deciding the drug did not demonstrate a favorable benefit-to-risk ratio.
Prior to making its decision, the FDA advisory committee reviewed results of 17 trials that included more than 1,000 patients.
“While we are disappointed with the outcome of the ODAC vote, we remain confident in the efficacy, safety and tolerability of tivozanib in RCC patients,” Tuan Ha-Ngoc, AVEO’s president and chief executive officer, said in a press release. “We are committed to the RCC 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.”
The FDA often follows the advisory committee’s recommendations but is not obligated to do so. The FDA review of the new drug application for tivozanib is scheduled to be completed by July 28.