FDA’s Elimination of REMS for CAR T Cell Therapies

The FDA has removed the Risk Evaluation and Mitigation Strategy (REMS) requirements for all six currently approved autologous chimeric antigen receptor (CAR) T lymphocytes (T cell) therapies. All of these therapies target B-cell maturation antigen (BCMA) or the cluster of differentiation 19 (CD19) molecule in certain blood cancers. Since the first CAR T cell approval in 2017, these products were tightly controlled under REMS programs due to the risk of life-threatening cytokine release syndrome (CRS) and neurotoxicities. The REMS mandated that hospitals be specially certified and have tocilizumab on hand to treat severe CRS, and patients were required to stay near the treatment location for up to four weeks post-infusion. Over time, oncologists and hospitals have gained extensive experience in managing these side effects. Thus, the FDA announced that a dedicated REMS is no longer necessary to ensure benefits outweigh the risks.^1,2

product name	target antigen	year of first fda approval
Abecma (idecabtagene vicleucel)	BCMA	2021
Breyanzi (lisocabtagene maraleucel)	CD19	2021
Carvykti (ciltacabtagene autoleucel)	BCMA	2022
Kymriah (tisagenlecleucel)	CD19	2017
Tecartus (brexucabtagene autoleucel)	CD19	2020
Yescarta (axicabtagene ciloleucel)	CD19	2017

Key Changes

With the REMS in place, patients could only receive CAR T cell treatments at fewer than 160 authorized centers across the country.^3-9 Elimination of the REMS program removes the special hospital certification and on-site medication requirements that were previously in place. Going forward, any qualified treatment center can administer CAR T cell therapies as long as they adhere to updated prescribing guidelines. The revised product labels should reduce burdens on patients and providers. For instance, the recommended post-infusion observation period near a healthcare facility has been shortened from four weeks to two weeks, and patients are advised not to drive for two weeks after treatment (down from eight weeks). These changes reflect the FDA’s confidence that serious reactions are unlikely beyond the early post-treatment period and can be diagnosed and managed by the established guidelines and extensive experience of the medical community. Importantly, all critical safety information, including the boxed warnings about CRS and neurotoxicity, remains in place in product labels and Medication Guides.

Implications and Outlook

Prior restrictions imposed by the REMS contributed to the fact that only a fraction of eligible patients have actually received CAR T cell treatment.¹⁰ With the REMS eliminated, patients will be able to receive CAR T cell treatments in more than just highly specialized centers. Similarly, many who previously had to travel or temporarily relocate to receive CAR T cell treatment may now receive therapy closer to home. Lifting these barriers should significantly increase the rates at which eligible patients are treated.

For healthcare providers and trial sponsors, the regulatory burden is reduced. They no longer need to maintain FDA REMS certifications or keep certain emergency drugs solely for compliance. That said, the FDA makes clear that standard adverse event reporting and post-marketing safety studies, including 15-year patient follow-up, are still required. In practice, clinicians must continue to monitor for CRS and neurological events just as diligently, even without the extra REMS requirements.

In summary, the FDA’s removal of REMS requirements is a milestone for CAR T cell therapies that will facilitate their wider use. The change balances the need for improved access with ongoing safety oversight, aiming to streamline the use of CAR T cell therapies while continuing to manage risks responsibly. As newer-generation CAR T cell therapies are eventually approved by the FDA, such an approach will be critical for broader success.

If your study involves CAR T cell therapies or you have questions about REMS implications, reach out to WCG’s IBC experts. Our team is here to help you navigate regulatory changes and ensure your research remains compliant and patient-centric.

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References:

1. U.S. Food and Drug Administration. “FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous CAR T Cell Immunotherapies.” FDA Vaccines/Biologics Safety Communication, June 26, 2025.
2. U.S. Food and Drug Administration. “FDA Eliminates REMS for Autologous CAR T Cell Therapies.” FDA Press Announcement, June 26, 2025.
3. Foundation for the Accreditation of Cellular Therapy (FACT). “Accredited U.S. Immune Effector Cell Therapy Programs.” FACT Accredited Centers Directory (USA), accessed July 8, 2025.
4. Bristol Myers Squibb. “Find a Treatment Center – Breyanzi.” Breyanzi HCP Website, accessed July 8, 2025.
5. Kite Pharma (Gilead). “Authorized Treatment Centers – Tecartus (ALL).” Tecartus HCP Website, accessed July 8, 2025.
6. Novartis. “Find a Kymriah Treatment Center.” Kymriah Patient Website, accessed July 8, 2025.
7. Janssen Biotech. “Authorized Treatment Centers – Carvykti.” Carvykti Website, accessed July 8, 2025.
8. Bristol Myers Squibb. “https://www.abecma.com/find-a-treatment-center.” Abecma Patient Website, accessed July 8, 2025.
9. Kite Pharma (Gilead). “Authorized Treatment Centers – Yescarta.” Yescarta HCP Website, accessed July 8, 2025.
10. Byrne MT, Lyss AJ, Mullangi S. “Key Challenges in CAR T-Cell Therapy Access in Community Oncology.” JAMA Oncology, published online March 6, 2025.