BioCentury
ARTICLE | Company News

Aveo shares drop with uncertainty of NDA submission for Fotivda

January 31, 2019 7:23 PM UTC

Aveo Pharmaceuticals Inc. (NASDAQ:AVEO) lost $1.07 (60%) to $0.70 Thursday after the company said it will not submit an NDA to FDA based on preliminary survival data from the Phase III TIVO-3 trial for Fotivda tivozanib as a third-line treatment of renal cell carcinoma (RCC).

Last November, Aveo said it would submit an NDA to FDA in about six months despite reporting preliminary data from TIVO-3 showing no overall survival (OS) benefit for Fotivda as a third-line treatment vs. Nexavar sorafenib (HR=1.12, p=0.69). The company designed TIVO-3 to address a 2013 complete response letter for Fotivda in which FDA expressed concern about a negative OS trend seen in the first Phase III trial, TIVO-1 (see "Aveo RCC Compound Trends Toward Detrimental Survival Effect, Again")...