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).

Powered by Atypic ®