CHMP issues guidance on MRD as CLL endpoint

EMA's CHMP published draft guidance that said minimal residual disease can be an approvable endpoint in chronic lymphocytic leukemia.

According to the guidance, "A difference in MRD response rates can be used as primary evidence of clinical benefit to obtain early licensure in randomised CLL trials designed to show superiority in terms of PFS," if multiple conditions are met. These conditions include "The difference in MRD response rate between study arms is large enough to predict that a relevant PFS benefit will appear on mature data," and that "PFS confirmation will be obtained at a further analysis with the trial being prospectively powered for this purpose." ...