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# ODAC to Discuss Minimal Residual Disease Endpoint
- URL: https://www.fdaweb.com/odac-to-discuss-minimal-residual-disease-endpoint/
- Published: 2024-04-10T12:00:00.000Z
- Updated: 2026-09-14T14:27:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156751

The Oncologic Drugs Advisory Committee meets on 4/12 to discuss using minimal residual disease (MRD) as an endpoint in multiple myeloma (MM) clinical trials. An agency briefing document developed in conjunction with two applicants, the University of Miami and 12TEAMM, and distributed in advance of the meeting, says that no specific products will be presented or discussed at the meeting.

The committee will be asked to evaluate the totality of the data and to discuss the adequacy of the data to support the use of MRD as an endpoint to support accelerated approval in MM clinical trials.

FDA concludes that “the applicants have worked with the broader MM community to develop a novel endpoint of MRD that has the potential to expedite drug development in MM. While there are still outstanding questions on how to best use MRD, the meta-analyses conducted represent robust assessments of MRD that support its prognostic value, provide information regarding the appropriate timing of MRD assessment, and suggest that MRD may be appropriate to use as an intermediate clinical endpoint to support accelerated approval.”