Visual abstract | Optimizing post-treatment monitoring following CAR T-cell therapy: Policy changes and adverse event data

On June 27, 2025, the U.S. Food and Drug Administration (FDA) removed the Risk Evaluation and Mitigation Strategies (REMS) requirements for all approved autologous chimeric antigen receptor (CAR) T-cell therapies, based on consistent safety data from clinical trials and real-world studies.^1,2 

This decision is expected to lower logistical burdens, reduce referral-to-treatment times, and improve access for patients, particularly for those in rural areas.³

This decision is consistent with results from an analysis of the timing of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) in patients who received lisocabtagene maraleucel (liso-cel) in clinical trials (TRANSCEND NHL-001, TRANSCEND CLL-004, TRANSFORM, PILOT, TRANSCEND FL; n = 702), or in a real-world setting using the Center for International Blood and Marrow Transplant Research (CIBMTR) registry (n = 877). Results from this analysis were presented by Kamdar et al.⁴ at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, May 30 – June 3, 2025, Chicago, US, and showed that the majority of CRS/ICANS events occurred within the first 15 days post-infusion.