By Jonah Feldman, Frederick Locke, MD – Targeted Oncology –
On June 26, 2025, the FDA announced the elimination of the Risk Evaluation and Mitigation Strategy (REMS) program that applied to 6 chimeric antigen receptor (CAR) T-cell therapies approved to treat patients with leukemia, lymphoma, or multiple myeloma.1 Additionally, labels for these therapies were modified in terms of requirements for monitoring, remaining in proximity to the treatment center, and driving vehicles after CAR T-cell infusion.
The REMS program was no longer necessary because of the accumulated experience gained over years of CAR T-cell use post approval. The decision had been called for by groups such as the American Society for Transplantation and Cellular Therapy (ASTCT), which argued the REMS requirements increased barriers to access to vital treatments for patients and created additional burdens for treatment centers that provided CAR T-cell therapies.
