MRD-Based End Point Set to Surge Under FDA Guidance in Multiple Myeloma

“We’ve been slow walking this [MRD] process for years, understandably, given what’s at stake here with drug approvals, but this is what we need for our patients.”

Recent leaps of progress in multiple myeloma treatments have been constrained by time. Despite having more effective therapies for patients, traditional end points like progression-free survival (PFS) and overall survival (OS) take years to mature and prevent new treatments from getting to patients sooner. In efforts to combat this, the field has shifted to focusing on minimal residual disease (MRD) and complete response (CR) as supporting end points for accelerated approvals. The FDA issued draft guidance in January 2026 for using MRD as an end point in multiple myeloma to support accelerated approvals.

Malin Hultcrantz, MD, PhD, Rahul Banerjee, MD, FACP, and Marc J. Braunstein MD, PhD, all shared their thoughts on the draft guidance and it’s implications for the multiple myeloma treatment paradigm. Hultcrantz is an assistant attending physician at Memorial Sloan Kettering Cancer Center. Banerjee is an assistant professor in the Clinical Research Division of Fred Hutch Cancer Center and the University of Washington School of Medicine. Braunstein is an associate professor in the Department of Medicine at NYU Grossman Long Island School of Medicine, director of the Fellowship Program, Hematology and Oncology, at NYU Langone Health.

The process of utilizing MRD as a primary end point has already been used in clinical trials like the phase 3 CEPHEUS study (NCT03652064) which eventually supported the January 2026 FDA approval of daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone (VRd) for newly diagnosed multiple myeloma.

“At the end of the day, we’re looking to choose the best regimen for our patients and prolong their survival, and MRD can be helpful as a surrogate marker for their relapse, or even to see what their prognosis is, as well as make clinical decisions,” Braunstein said.

For more expert insights, in-depth data about MRD-based end points in multiple myeloma, and information about the FDA draft guidance, be sure to check out our feature on the topic.