Surrogate Endpoints Acceptable in AML Trials, Says FDA

“The central finding of the article, that both EFS and the CR rate are reliably associated with improved OS, is of immediate relevance and indicates that these parameters represent acceptable and appropriate surrogate end-points for clinical trials of AML,” say Courtney DiNardo, University of Texas MD Anderson Cancer Center, Houston, Texas, and Daniel Pollyea, University of Colorado, Aurora, Colorado, in an accompanying editorial.