In a unanimous vote, the FDA Oncologic Drugs Advisory Committee advised the agency to accept the metric of “minimal residual disease,” or MRD, as a basis for accelerated approvals of therapies in all settings of multiple myeloma.
The U.S. Food and Drug Administration and the U.S. Department of Health and Human Services Office of Human Research Protections issued Draft Guidance on the inclusion of tissue biopsies in clinical trials.
