The FDA released a draft guidance in January 2026 intended to give recommendations to investigators leading multiple myeloma trials on using minimal residual disease (MRD) and complete response (CR) as primary endpoints in clinical trials. The agency said the guidance is intended to help drug sponsors in securing accelerated approval for new myeloma therapies.
According to the document, investigators should measure MRD negativity in the bone marrow of patients who have already acheived a CR. The FDA recommends using either flow cytometry or sequencing-based methods for these assessments to ensure the data is robust enough to support an early approval for new treatments.
In 2025, an article published in The Lancet Haematology, unrelated to the current regulatory guidance, called for further research into the use of MRD in hematologic malignancies to guide treatment decisions, and warned that hematologists should remain wary of the often unquestioned assumptions that accompany MRD.
