Anti-cancer drug approved based on a surrogate endpoint

Surrogate endpoint for overall survival

surrogate endpointWe managed to prove, using data from a randomized trial comparing Ceplene + IL-2 to no maintenance treatment, that leukemia free survival was a good surrogate endpoint for overall survival in patients in complete remission (Haematologica 2011). We also showed through meta-analysis that IL-2 alone was not better than no maintenance treatment in this patient population (Blood 2011). These facts resulted in the approval of Ceplene (from Epicept, then taken over by MEDA).