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# Panel Backs Minimal Residual Disease Endpoint
- URL: https://www.fdaweb.com/panel-backs-minimal-residual-disease-endpoint/
- Published: 2024-04-12T12:00:00.000Z
- Updated: 2026-09-14T14:28:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156773

FDA’s Oncologic Drugs Advisory Committee 4/12 unanimously voted (12 to 0) that the totality of data are adequate to support the use of minimal residual disease (MRD) as an endpoint to support accelerated approval in multiple myeloma (MM) clinical trials.

Two applicants — the University of Miami and 12TEAMM — “worked with the broader MM community to develop a novel endpoint of MRD that has the potential to expedite drug development in MM,” an FDA [briefing document](https://www.fda.gov/media/177652/download?ref=fdaweb.com) released in advance of the meeting says. “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.”

After the vote, panel chair and National Cancer Institute senior clinician of prostate cancer clinical research **Ravi Madan** had this to say: “The FDA showed that MRD does fall short of true surrogacy, but that’s a high bar, and that wasn’t the question today. Our clinical experts and the FDA both agree that MRD does meet the criteria for accelerated approval, and that’s why I voted yes.” He cautioned that once word gets out about MRD being acceptable for accelerated approvals, “it will change the incentive structure for preclinical modeling, clinical development, and early clinical trials, so that requires the FDA to be vigilant.

"We talked a little bit about how that may lead to throwing the baby out with the bathwater, as financial incentives may pressure industry to hit the MRD mark or decide not to continue,” Madan continued. “On the flip side, it could raise other concerns that hitting MRD may not translate into long-term clinical efficacy. Therefore, the FDA needs to pay close attention as it always does, to safety, progression-free survival, and other relevant points like survival.”