Key Takeaways
- FDA Removes Risk Evaluation and Mitigation Strategy (REMS) for chimeric antigen receptor (CAR) T-cell Therapies: Updated labels for Breyanzi and Abecma eliminate REMS requirements, reflecting improved safety management in clinical practice.
- Monitoring Requirements Reduced: Post-treatment driving and location restrictions have been cut in half, easing the burden on patients and caregivers.
- Push to Expand Community Access: Bristol Myers Squibb aims to bring CAR T-cell therapies to more community cancer centers, improving treatment accessibility for eligible patients nationwide.
The FDA has approved streamlined label updates for Bristol Myers Squibb’s (BMS) chimeric antigen receptor (CAR) T-cell therapies, Breyanzi for large B-cell lymphoma and other lymphomas and Abecma for multiple myeloma (MM), marking a significant step toward improving patient access. According to the company, the updates reduce certain post-treatment monitoring requirements and eliminate the Risk Evaluation and Mitigation Strategy (REMS) programs that were required at the time of each therapy’s initial approval.1
How Will the Label Changes Improve CAR T Access for Blood Cancer Patients?
“CAR T-cell therapy is a transformational, potentially life-saving option for patients living with blood cancers, and we are working to challenge current practices, assumptions and barriers that limit access,” said Lynelle B. Hoch, president, cell therapy organization, BMS, in a press release. “Today's FDA-approved label updates reinforce BMS’ continued efforts to collaborate across the healthcare ecosystem, with the ultimate goal of reaching more patients and democratizing access to cell therapy.”
REMS Removal and Monitoring Updates Ease Burden on Patients and Providers
Under the revised labels, driving restrictions have been shortened from eight to two weeks post-treatment, and the requirement to remain near a healthcare facility after infusion has been reduced from four to two weeks. The FDA also approved the removal of REMS requirements from both product labels.
Although REMS programs are typically used to manage risks associated with new therapies, the FDA determined that current treatment guidelines, combined with the hematology and oncology community’s experience, are sufficient to monitor for known adverse events, such as cytokine release syndrome and neurologic toxicities, eliminating the need for additional regulatory oversight.
BMS Aims to Expand Community-Based Access to Cell Therapy
BMS stated that the updates align with its broader initiative to reduce logistical and geographic barriers that have historically limited CAR T uptake—currently reaching only about 20% of eligible patients. The company is working with more than 150 certified treatment centers to implement the changes and plans to expand access through community oncology sites.1
FDA Maintains Support for CAR T-cell Therapies Despite Safety Concerns
The move comes amid heightened FDA focus on CAR T-cell therapy safety and benefit-risk balance. In a New England Journal of Medicine commentary published in January, Peter Marks, MD, PhD, former director of the FDA’s Center for Biologics Evaluation and Research (CBER), and Nicole Verdun, MD, former director of CBER’s Office of Therapeutic Products, acknowledged that although CAR T-cell therapies offer substantial clinical benefit, their safety profiles require ongoing vigilance.2
“The demonstrated efficacy of the current generation of approved CAR T products comes along with several well-described safety concerns that are noted in the products’ labeling, including risks of cytokine release syndrome, immune effector cell–associated neurotoxicity syndrome, various forms of cytopenia, and hypogammaglobulinemia,” they wrote, in the commentary. “Better understanding of some of these risks has led to improved outcomes, such as for patients who develop cytokine release syndrome.”2
Currently Approved CAR T-cell Therapies in the United States
Including Breyanzi and Abecma, six CAR T-cell therapies have received FDA approval to date. These include:
Kymriah (tisagenlecleucel): For B-cell acute lymphoblastic leukemia (ALL) and B-cell non-Hodgkin lymphoma (NHL)
Yescarta (axicabtagene ciloleucel): For NHL and follicular lymphoma
Tecartus (brexucabtagene autoleucel): For mantle cell lymphoma and ALL
Carvykti (ciltacabtagene autoleucel): For MM.2
Patient Advocates Welcome Reduced Burden
"Living with blood cancer is challenging, but patients and their loved ones still need to maintain jobs, take care of families, and plan for the future,” said Sally Werner, CEO, Cancer Support Community, in the press release. “Today’s announcement reduces some of the most onerous requirements that may have previously discouraged patients, particularly those who live far from a treatment center, from seeking the potentially transformational effects of cell therapy. We applaud any and all efforts to continue to break down barriers, reduce time burden on patients and caregivers, and increase uptake of this life-saving therapy."
References
U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb’s Cell Therapy Labels. BMS. June 26, 2025. Accessed June 27, 2025. https://news.bms.com/news/details/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
FDA Urges Caution Following Boxed Warning Requirements on CAR T-Cell Therapies. PharmExec. January 25, 2025. Accessed June 27, 2025. https://www.pharmexec.com/view/fda-urges-caution-following-boxed-warning-requirements-on-car-t-cell-therapies
