FDA removes REMS from CAR-T cell therapies

The U.S. FDA has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous CAR-T cell therapies, in a move to minimize the burden on the health care delivery system.

According to the agency, the REMS safety program is no longer necessary to ensure that the benefits of CAR-T cell immunotherapies outweigh their risks, which include cytokine release syndrome and neurological toxicities.

In addition, product labeling was updated to align with REMS elimination and streamline patient monitoring following product administration. Specifically, driving restrictions have been reduced from 8 weeks to 2 weeks post treatment and the requirement to stay within proximity of a health care facility following infusion has been reduced from 4 weeks to 2 weeks.

The label updates apply to the six currently-approved CAR-T cell therapies that carried REMS warnings: Gilead’s Yescarta and Tecartus, J&J’s Carvykti marketed with Legend Biotech, and Novartis’s Kymriah.

Autolus Therapeutics’ Aucatzyl, approved in November 2024 for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, was the first CAR-T cell therapy approved by the FDA with no REMS requirement. The B-lymphocyte antigen CD19 CAR-T cell therapy was designed to overcome the limitations in clinical activity and safety compared to current CD19 CAR-T cell therapies. The treatment is designed with a fast target binding off-rate to minimize excessive activation of the programmed T cells.