CAR T REMS Elimination Eases Burden on Treatment Centers

Frederick L. Locke, MD, chair of the Department of Blood and Marrow Transplant and Cellular Immunotherapy at Moffitt Cancer Center in Tampa, Florida, discusses the 2025 removal of the Risk Evaluation and Mitigation Strategy (REMS) program for chimeric antigen receptor (CAR) T-cell therapy and the resulting improvements to patient access.

Locke, who coauthored the American Society of Transplantation and Cellular Therapies (ASTCT) white paper arguing that the REMS program was no longer necessary, described how the FDA was moving toward reducing restrictions by 2024. In June 2025, shortly after the ASTCT’s white paper was published, the FDA eliminated the REMS program.

Locke says this represents a recognition that CAR T centers have overcome many safety challenges with greater experience. The outcomes include the opening of more CAR T programs due to lower costs, easier logistics, and easing the burden on existing programs. These changes can reduce the number of patients who do not receive CAR T-cell therapy for hematologic malignancies despite being eligible.

TRANSCRIPTION

0:10 | We came up with a white paper about some of the things that were already in place that sort of abrogated the need for this REMS program with CAR T. In fact, by the time we published our white paper, the FDA had already walked back, to some degree, some of the REMS requirements. By July of 2024, the FDA was already saying, "We don't need you to have a wallet card given to patients. We don't need you to record the training and education sessions for these physicians."

0:43 | And then, subsequent to that, after we published our white paper, the FDA removed the REMS completely for CAR T-cell therapy administration. By June of 2025, there's no more REMS, and there's a recognition that we as a community are able to safely administer these treatments to our patients. So I think ultimately this does increase access to the therapy. It allows more treatment centers to open up to provide CAR T and allows us to utilize the resources and the infrastructure we already have in place without this added layer of the REMS and FDA oversight of a standard-of-care, FDA-approved therapy.