FDA Simplifies Reporting for CAR T-Cell Therapies with REMS Update

The Food and Drug Administration has broadened its modified approval of risk evaluation and mitigation strategies (REMS) for chimeric antigen receptor (CAR) T-cell therapies to encompass all six FDA-approved therapies. Through the modified REMS, the agency aims 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. The currently approved REMS are available online at REMS@FDA.