FDA

FDA removes REMS requirements for autologous CAR T-cell therapies

July 3, 2025

On June 27, 2025, FDA announced the removal of Risk Evaluation and Mitigation Strategies (REMS) for all currently approved autologous chimeric antigen receptor (CAR) T-cell therapies targeting BCMA and CD19 antigens. This decision affects six gene therapies—Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, and Yescarta—used in the treatment of hematologic malignancies such as multiple myeloma, leukemia, and lymphoma.

FDA determined that REMS programs are no longer necessary to ensure the benefits of these therapies outweigh their risks, citing the maturity of clinical experience and the adequacy of current product labeling, which includes boxed warnings for cytokine release syndrome (CRS) and neurologic toxicities.

The elimination of REMS requirements lifts the mandate for hospitals and clinics to be specially certified and to maintain immediate on-site access to tocilizumab, a key treatment for CRS. According to the agency, this move reduces administrative burden on clinicians and may expedite patient access to these potentially curative therapies. “Physicians and institutions now have greater experience identifying and managing toxicities with the currently approved CAR T products,” said Dr. Richard Pazdur, Director of FDA’s Oncology Center of Excellence. The agency emphasized that it will continue to monitor the safety of these biologics and update the public as new data emerge.

Sources:

(2025, June 27). FDA. FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies [FDA News Release]. https://www.fda.gov/news-events/press-announcements/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen-receptor

(2025, June 26). FDA. FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies [FDA Safety Communication]. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen-receptor