FDA Determines CAR-T Can Be Safely Given Without Risk Evaluation and Mitigation Strategies (REMS)

Learn why the U.S. Food and Drug Administration (FDA) removed safety restrictions called Risk Evaluation and Mitigation Strategies (REMS) from several CAR T-cell therapies, and how this may make treatment more accessible for people living with blood cancer. 

FDA removes extra safety restrictions on CAR T-cell therapies

The FDA announced on June 27, 2025 that it no longer requires REMS for any of the currently approved BCMA- and CD19-directed autologous CAR T-cell therapies. These personalized cell-based treatments are used to treat multiple myeloma and certain types of lymphoma and leukemia.

REMS is a safety program the FDA sometimes requires for medicines with serious side effects. It’s meant to help ensure the benefits of a treatment outweigh its risks. After years of monitoring, the FDA has determined that the current CAR T-cell therapies can continue to be used safely without REMS.

CAR-T brands that no longer require REMS

The decision affects six CAR T-cell therapies currently approved in the U.S.:

• Axi-cel (axicabtagene ciloleucel, Yescarta, Kite)
  • Affects: Relapsed/refractory (R/R) large B-cell lymphoma (LBCL) and R/R follicular lymphoma
• Brexu-cel (brexucabtagene autoleucel, Tecartus, Kite)
  • R/R mantle cell lymphoma (MCL) and R/R B-cell precursor acute lymphoblastic leukemia (ALL)
• Cilta-cel (ciltacabtagene autoleucel, Carvykti, Johnson & Johnson)
  • R/R multiple myeloma
• Ide-cel (idecabtagene vicleucel, Abecma, Bristol-Myers Squibb)
  • R/R multiple myeloma
• Liso-cel (lisocabtagene maraleucel, Breyanzi, Bristol-Myers Squibb)
  • R/R LBCL, R/R follicular lymphoma, R/R MCL, and R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
• Tisa-cel (tisagenlecleucel, Kymriah, Novartis)
  • R/R B-cell precursor ALL, R/R LBCL, R/R follicular lymphoma

This change removes the requirement for hospitals and treatment centers to be specially certified and to have the medicine tocilizumab immediately available onsite. Tocilizumab is used to treat certain side effects, such as cytokine release syndrome and neurologic toxicities (ICANS), which can occur with CAR-T.

Instead, the FDA says all needed safety information is now included in the product labels and medication guides.

Real-world experience helped inform the FDA's decision

More than 30,000 patients have now received CAR T-cell therapy. Most serious side effects happen within the first two weeks after treatment. Doctors and nurses have become more skilled at spotting and treating these complications early. 

Because of this growing expertise, the FDA believes the strict REMS program is no longer necessary. The agency will continue to monitor the safety of these therapies through required long-term follow-up, including tracking side effects.

This ongoing safety oversight is important for patients to understand. It means that while REMS is going away, patient safety remains a top priority.

Some safety monitoring rules have been eased

With the removal of REMS, certain safety requirements have also been reduced. For example:

• The required stay near a treatment center after infusion has been shortened from four weeks to two weeks.
• Driving restrictions have been reduced from eight weeks to two weeks after treatment.

These changes can make treatment less disruptive to daily life. People who live far from a certified treatment center, or who work or care for family members, may find it easier to plan and recover from CAR-T.

Aiming to increase access to CAR-T 

Currently, only about 2 in 10 eligible patients receive CAR-T. Geographic and logistical barriers make it hard for many to access these treatments. The FDA’s recent changes aim to reduce these hurdles. 

To help more patients receive CAR T-cell therapy closer to home, Bristol Myers Squibb—the maker of ide-cel and liso-cel—is working to expand access through additional community cancer centers.

This matters for patients because shorter travel, fewer hospital requirements, and simplified monitoring can make it easier to say yes to this type of care. 

“The FDA has taken the bold step to remove the Risk Evaluation and Mitigation Strategy requirement from giving CAR T therapies. REMS is a useful safety system, but reevaluation over time helps inform whether a REMS is still needed to ensure that the benefits of a product outweigh its risks. Eliminating the REMS that is no longer needed also expedites the delivery of potentially curative treatments to patients and reduces burden on providers.” -Vinay Prasad, M.D., M.P.H., FDA Chief Medical and Scientific Officer and Director, Center for Biologics Evaluation and Research.

Summary

The FDA has removed the REMS safety program from all current BCMA- and CD19-directed autologous CAR T-cell therapies based on growing evidence and real-world use. These changes could make treatment more accessible and less burdensome for many. Long-term safety monitoring will continue.

Easily contribute to blood cancer research

The decision to remove REMS was partly based on real-world experience shared by thousands of patients. You can help improve access and safety of treatments like CAR-T by taking part in real-world studies through simple surveys in HealthTree Cure Hub®.

Make an Impact with Brief Blood Cancer Surveys

See Patients’ Progress: Research Results News

Sources: 

• U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb’s Cell Therapy Labels
• FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies