Aveo could lose Fotivda's EU approval if August analysis confirms negative OS trend

EMA's CHMP will consider regulatory action should an interim overall survival analysis of Fotivda tivozanib, planned for August, confirms the negative OS trend that Aveo disclosed in an April 3 SEC filing.

The European Commission approved Fotivda from Aveo Pharmaceuticals Inc. (NASDAQ:AVEO) in 2017 to treat advanced renal cell carcinoma (RCC) based on data from the Phase III TIVO-1 trial. While Fotivda met the primary endpoint of improving progression-free survival (PFS) vs. Nexavar sorafenib, the compound showed a negative trend on the secondary endpoint of OS...