FDA draft guidance describes bone-marrow MRD negativity plus complete response as an accelerated-approval endpoint in myeloma
On January 21, 2026, the FDA released draft guidance on using minimal residual disease and complete response in multiple myeloma to support accelerated approval, defining the MRD endpoint as bone-marrow negativity by flow cytometry or sequencing in patients who have achieved complete response or stringent complete response, and noting that the April 12, 2024 ODAC unanimously accepted MRD as an accelerated-approval endpoint.
Federal Register