For Many, CAR T is a Miracle Therapy – We Need to Get it to More Patients

The U.S. Food & Drug Administration (FDA) recently removed its Risk Evaluation and Mitigation Strategies (REMS) designation from CAR T immunotherapies. REMS is occasionally applied to drugs with serious potential safety issues, requiring providers to pursue and document more robust mitigation strategies.

The FDA puts these designations in place to ensure patients receive the maximum therapeutic benefits, and providers fully manage severe side effects. While CAR T has been a transformative therapy, redefining what’s possible in oncology, it can also be quite toxic. In this case, the culprits are cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).

Removing the designation is a routine, and probably warranted, regulatory change. Kymriah was