FDA takes step toward innovation-supporting endpoints with MRD negativity guidance

Almost two years after an FDA advisory committee voted unanimously in favor of MRD negativity as a surrogate endpoint in multiple myeloma trials, the agency is acting on the recommendation with new draft guidance. The move reflects the agency’s promise to innovate on oncology endpoints and quiets fears of FDA constructing new accelerated approval barriers. 

At the Nov. 11, 2024, meeting of the Oncologic Drugs Advisory Committee (ODAC), panel members made the case that use of measurable residual disease (MRD) negativity — also known as minimal residual disease negativity — as a surrogate endpoint in multiple myeloma trials was necessary to support future innovation for the disease. ...