Removal of REMS Requirements Could Help Streamline CAR T-Cell Therapy Access in Hematologic Cancer Care

The FDA’s decision to remove Risk Evaluation and Mitigation Strategies (REMS) programs for BCMA- and CD19-directed autologous CAR T-cell therapies could help streamline and improve access to these treatment for select patients with hematologic malignancies, according to a letter to the editor published in Transplantation and Cellular Therapy.1,2

In the letter from Muhammad Bilal Abid, MD, MS, FACP, MRCP, FRCP, of the Department of Hematology/Oncology at the University of Texas Health Science Center and the Department of Stem Cell Transplantation and Cellular Therapy at the University of Texas MD Anderson Cancer Center in Houston; Noufil Adnan, MD, of the Department of Internal Medicine at the University of Kansas Medical Center in Wichita; and Nausheen Ahmed, MD, of the Division of Hematological Malignancies and Cellular Therapeutics, Department of Medicine, University of Kansas Cancer Center in Westwood, the authors underscored that although CAR T-cell therapy has helped revolutionize the management of select relapsed/refractory hematologic malignancies, the REMS requirements previously served as one of the limiting factors that restricted access to the agents for some patients, particularly those from underserved populations.1

With the FDA’s decision to remove the REMS requirements for BCMA- and CD19-directed CAR T-cell therapies, the regulatory agency reduced the time period of driving restrictions for patients from 8 weeks to 2 weeks following treatment, and patients are now required to stay within proximity of the health care facility for only 2 weeks following infusion, compared with the prior mandate of 4 weeks.3

“The cellular therapy community views this decision [to remove REMS requirements] as a landmark step toward easing the burden on patients and caregivers, reducing access disparities, and providing each patient in need of CAR-T a chance at a cure,” Abid and colleagues wrote.1 “This pivotal shift was driven by feedback from clinical experts who demonstrated, with real-world evidence, that toxicity can be safely managed without the burdens of REMS, and that access and safety are not mutually exclusive.”

Why Did the Authors Support the Removal of REMS Requirements?

REMS programs for CAR T-cell therapy were put in place from the outset of the first approved agent—tisagenlecleucel (Kymriah)—and continued with subsequent approved therapies. Notably, obecabtagene autoleucel (Aucatzyl) was the first CAR T-cell therapy approved without a REMS program, with the FDA greenlighting the agent for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia in November 2024.1,4

REMS programs were established to help address concerns with toxicities associated with CAR T-cell therapy, such as cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS).1 These initiatives were intended to establish formal training, certify treatment centers, and standardize protocols for monitoring and managing adverse effects in patients undergoing CAR T-cell therapy.

“Autologous CAR T-cell therapies represented a groundbreaking advancement in oncology, offering unprecedented hope for patients with relapsed and refractory hematologic malignancies,” authors wrote. “However, the promise related to homogeneous access to CAR [T-cell] therapy was diminished by concerns regarding the risk of severe and potentially life-threatening toxicities.”

Despite the intentions of the REMS programs, Abid and colleagues noted that these requirements were associated with several issues within real-world care. They explained that limited access for underserved populations impacted survival outcomes. Additionally, as clinicians became more experienced in the recognition, prevention, and management of AEs such as CRS and ICANS, these toxicities were no longer the primary driver of non-relapse mortality.

Finally, with real-world evidence highlighting the rarity of CRS or ICANS occurring more than 2 weeks post-transfusion, the need for stringent oversight guidelines became less necessary.

What Are the Clinical Implications of the Removal of REMS Programs for Select CAR T-Cell Therapies?

With reduced monitoring guidelines following the infusion of CAR T-cell therapy, these agents could now be more broadly administered across academic centers, along with resourceful community practices, the authors wrote. With potential access in the community, they also explained that the door is open for more meaningful partnerships between academic and community sites to ensure that patients receive better access to care.

With proper training, standardized protocols, and communication pathways, integrating community practices into the treatment model can help lower the need for long inpatient stays and long-distance travel to receive treatment and undergo monitoring.

“The FDA’s agreement reflects both scientific maturity and regulatory responsiveness, marking a moment to celebrate the collective efforts of the CAR T community in expanding access while maintaining high standards of patient care,” Abid and colleagues wrote.

With other aspects of CAR T-cell therapy—such as baseline assessments, imaging, laboratory work, and lymphodepletion chemotherapy—becoming more common at well-supported sites outside of academic centers, the end of the REMS requirements signals a further shift to prioritizing patient access and streamlining care.

“The end of REMS is more than just a regulatory change—it is a catalyst for democratizing access, reducing delivery costs and patient burden, academic-community-industry collaboration, and innovation across the CAR-T ecosystem,” the authors concluded.

Reference

1. Abid MB, Adnan N, Ahmed N. From risk to reach: how REMS remediation will shape CAR-T access. Transplant Cell Ther. 2025. doi:10.1016/j.jtct.2025.07.014REMS news
2. FDA eliminates Risk Evaluation and Mitigation Strategies (REMS) for autologous chimeric antigen receptor CAR T cell immunotherapies. FDA. June 27, 2025. Accessed October 10, 2025. https://www.fda.gov/news-events/press-announcements/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen-receptor
3. U.S. Food and Drug Administration approves streamlined patient monitoring requirements and removal of REMS programs within Bristol Myers Squibb’s cell therapy labels. News release. Bristol Myers Squibb. June 26, 2025. Accessed October 10, 2025. https://news.bms.com/news/corporate-financial/2025/U-S--Food-and-Drug-Administration-Approves-Streamlined-Patient-Monitoring-Requirements-and-Removal-of-REMS-Programs-within-Bristol-Myers-Squibbs-Cell-Therapy-Labels/default.aspx
4. FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. FDA. November 8, 2024. Accessed October 10, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-obecabtagene-autoleucel-adults-relapsed-or-refractory-b-cell-precursor-acute