The US Food and Drug Administration (FDA) has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for all currently approved BCMA- and CD19-directed autologous chimeric antigen receptor (CAR) T-cell therapies.
Previously available only through a restricted REMS program, the following therapies are affected:
- Idecabtagene vicleucel (Abecma)
- Lisocabtagene maraleucel (Breyanzi)
- Ciltacabtagene autoleucel (Carvykti)
- Tisagenlecleucel (Kymriah)
- Brexucabtagene autoleucel (Tecartus)
- Axicabtagene ciloleucel (Yescarta)
The FDA stated in a press release that the REMS protocol is “no longer necessary to ensure that the benefits of these CAR T cell immunotherapies outweigh their risks and to minimize the burden on the healthcare delivery system.”
The agency cited the hematology/oncology community’s extensive experience managing risks associated with CAR T-cell therapy, particularly cytokine release syndrome (CRS) and neurologic toxicities, as reasoning behind the change. Adverse event reporting for CRS and neurologic events has remained stable, the FDA said.
Risk information for these products will continue to be conveyed through existing product labeling, which includes boxed warnings and medication guides.
