Authored by Brian Koffman, MDCM (retired), MSEd
Bottom Line:
The FDA’s mandatory plans to manage drug risks, known as REMS (Risk Evaluation and Mitigation Strategies), were dropped for CAR-T, making it more accessible in CLL.
Discussion and Details:
On June 26th, the FDA eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous CAR-T cell therapies, concluding that REMS are no longer needed to ensure the benefits of these treatments outweigh their risks or to reduce the burden on the healthcare system. For patients with chronic lymphocytic leukemia (CLL), this means that lisocel or lisocabtagene maraleucel, a CD19-directed autologous CAR-T cell therapy, will be easier to administer. (BCMA CAR-T are used to treat multiple myeloma with great success.)
Key Impacts for CLL Patients:
- Improved Access to Care
Without the REMS requirements, more treatment centers, especially nonacademic community hospitals and smaller oncology practices, may be able to offer CAR-T cell therapies. Previously, REMS imposed strict training, infrastructure, and monitoring requirements that limited availability to specialized centers.
- Faster Treatment Timelines
With fewer regulatory and logistical hurdles, the time from referral to infusion could shorten. This is especially important for relapsed/refractory CLL patients who may not have the luxury of waiting weeks or months for therapy coordination.
- Reduced Burden on Healthcare Providers
Removing REMS reduces the administrative burden and training requirements for providers. This could increase the willingness of institutions to offer CAR-T therapy and improve the patient experience by streamlining care.
- No Change in Safety Monitoring Standards
Although REMS are no longer mandated, the FDA and manufacturers still expect CAR-T centers to follow rigorous protocols for managing serious side effects, such as cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS). The absence of REMS does not mean a relaxation in safety standards.
- Signal of Maturing Evidence Base
The FDA’s decision reflects growing confidence in the real-world safety profile of these therapies and broader clinician familiarity with managing associated toxicities. For CLL patients, especially those with limited treatment options, this finding affirms that CAR-T is becoming a more mainstream therapeutic consideration.
Conclusion:
Only approximately 20% of eligible patients currently receive cell therapy treatment. The removal of REMS is a positive development for CLL patients, potentially expanding access, accelerating treatment timelines, and reducing institutional barriers without compromising safety. However, the immediate impact may be minimal. Most existing access constraints such as cost, complexity, and the limited number of sites offering the therapy remain unchanged. The difficulty of the procedure and its efficacy leave it as a last resort for many patients. That said, this is a step in the right direction. It suggests the FDA’s growing confidence in CAR-T safety, helping to clear the path for future innovations and expanded access.
Links:
The official FDA press release can be found at FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T-Cell Immunotherapies.
Here is the press release from BMS, the manufacturer: U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb’s Cell Therapy Labels
