Cancer Trial Endpoints: Minimal Residual Disease Eyed As Surrogate

The use of minimal residual disease as a surrogate endpoint is eagerly awaited by industry due to the potential to speed development and approval of new treatments for hematological cancers – but there are still regulatory concerns to be overcome.

Discussion among FDA representatives and other stakeholders at a recent meeting suggests more work needs to be done to validate minimal residual disease (MRD) as a surrogate for clinical outcomes...