The U.S. Food and Drug Administration (FDA) “has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR T cell immunotherapies,” according to an announcement.
The FDA says REMS for the below 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)
Furthermore, “the elimination of REMS for the above products removes the requirements that hospitals and their associated clinics that dispense products must be specially certified and have on-site, immediate access to tocilizumab. The information regarding the risks for these CAR T cell immunotherapies can be conveyed adequately via the current product labeling, which includes a boxed warning for the risks of cytokine release syndrome and neurological toxicities, and medication guides.”
Additionally, “these products will continue to be subject to safety monitoring, through adverse event reporting requirements in accordance with regulations (21 CFR 600.80).” Eliminating the REMS for the mentioned products “does not change FDA requirements for manufacturers to conduct post marketing observational safety studies to assess the risk of secondary malignancies and long-term safety with follow up of patients for 15 years after product administration.”
