20 January 2026 - This guidance provides recommendations to sponsors about using minimal residual disease and complete response in multiple myeloma as primary outcomes in trials evaluating drug and biological products intended to treat patients with multiple myeloma to support approval under accelerated approval. 

For the purpose of this guidance, the minimal residual disease outcome refers to minimal residual disease negativity rate as assessed in the bone marrow by either flow cytometry- or sequencing-based methods in patients who have achieved a complete response. The definition of complete response includes patients who achieved complete response or stringent complete response.

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