FDA Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies Modified to Minimize Burden on Healthcare Delivery System (Catapult’s regulatory round-up – July 2024)
In line with section 505-1(g)(4)(B) of the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA has determined that the approved risk evaluation and mitigation strategies (REMS) for autologous chimeric antigen receptor (CAR) T cell immunotherapies (listed below), must be modified to minimize the burden of complying with the REMS on the healthcare delivery system. Therefore, REMS have been modified to remove requirements for educational and training materials. Please find further information here.
The currently approved autologous CAR T cell immunotherapies, available only through a restricted program under a REMS due to the risks of cytokine release syndrome (CRS) and neurological toxicities are:
- Abecma (idecabtagene vicleucel)
- Breyanzi (lisocabtagene maraleucel)
- Carvykti (ciltacabtagene autoleucel)
- Kymriah (tisagenlecleucel)
- Tecartus (brexucabtagene autoleucel)
- Yescarta (axicabtagene ciloleucel)
Published on the 1st of August 2024 in Catapult’s regulatory round-up for July 2024.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (5 novembre 2024). FDA Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies Modified to Minimize Burden on Healthcare Delivery System (Catapult’s regulatory round-up – July 2024). ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/12mjo





