Navigating MRD as an End Point in Hematologic Malignancies With Rahul Banerjee & Nicholas Richardson

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Published Jan 13, 2026

Read the full interview on Oncology Data Advisor:
https://oncdata.com/navigating-mrd-as-an-end-point-banerjee-richardson

Measurable residual disease (MRD) has quickly shifted from an exploratory biomarker to a central focus of clinical trial design and regulatory debate in hematologic malignancies. In this interview, Editorial Board member Rahul Banerjee, MD, FACP, speaks with Nicholas Richardson, DO, MPH, Vice President of Clinical Development at Precision for Medicine and former Deputy Director for the Division of Hematologic Malignancies 2 at the FDA, about how clinicians should interpret MRD assays, what “FDA‑cleared” actually means, and how the 2024 FDA Oncologic Drugs Advisory Committee (ODAC) on MRD in multiple myeloma is likely to shape future drug development.

Dr. Richardson explains the distinction between FDA‑cleared MRD assays such as clonoSEQ and FDA‑approved devices, clarifies why MRD does not yet meet strict Prentice criteria as a true surrogate for overall survival, and describes its current role as a candidate surrogate or intermediate clinical endpoint. They review the 2024 ODAC’s unanimous decision that MRD data are sufficient to support future accelerated approvals in myeloma, discuss why standardized thresholds (such as 10⁻⁵ in multiple myeloma) and assay‑agnostic validation are critical, and outline what trialists, sponsors, and practicing hematologist–oncologists should keep in mind as MRD and ctDNA are integrated into studies and regulatory pathways.

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