FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) Program for Certain Autologous CAR T-cell Therapies
July 1, 2025—According to this press release from the U.S. Food and Drug Administration, "The U.S. Food and Drug Administration announced today that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR T cell immunotherapies."
"These products are gene therapies that are currently approved to treat blood cancers, such as multiple myeloma and certain types of leukemia and lymphoma."
The press release noted, "The FDA determined that the approved REMS for the following products should be eliminated because a REMS is no longer necessary to ensure that the benefits of the autologous CAR T cell immunotherapies outweigh their risks.
- Abecma® (idecabtagene vicleucel)
- Breyanzi (lisocabtagene maraleucel)
- Carvykti® (ciltacabtagene autoleucel)
- Kymriah (tisagenlecleucel)
- Tecartus (brexucabtagene autoleucel)
- Yescarta (axicabtagene ciloleucel)"
Hospitals and clinics no longer need special certification or on-site access to tocilizumab to give these treatments. Safety information—such as the risk of cytokine release syndrome and neurological side effects—will now be shared through the product's label and medication guide.
These therapies will still be closely monitored. Manufacturers are still required to report side effects and conduct long-term safety studies for at least 15 years after treatment. To learn more, read the full press release from the FDA from the button below: