FDA Updates REMS for Brexucabtagene Autoleucel, Axicabtagene Ciloleucel

The Food and Drug Administration approved modifications to the risk evaluation and mitigation strategies (REMS) for two chimeric antigen receptor (CAR) T-cell therapies manufactured by Kite Pharma: axicabtagene ciloleucel (Yescarta) and brexucabtagene autoleucel (Tecartus).

These modifications aim to reduce the burden on the health care delivery system by eliminating the requirement to report serious adverse events suggestive of cytokine release syndrome (CRS) or neurological toxicities to the REMS. Additionally, FDA removed the requirement for certain educational and training materials.

Further information about the REMS for axicabtagene ciloleucel and brexucabtagene autoleucel is available online.