FDA guides on minimal residual disease endpoint in hematologic cancer trials

FDA Commissioner Scott Gottlieb highlighted minimal residual disease (MRD)'s potential as a surrogate endpoint in clinical trials when he unveiled FDA's draft guidance on using MRD in hematologic malignancy drug development in a statement Monday.

As early as 2012, FDA co-sponsored public workshops "to gain a better understanding of the state of the science of MRD," the agency wrote in the guidance (see "FDA to Discuss Minimal Residual Disease as Surrogate Endpoint")...