US FDA eliminates REMS for autologous chimeric antigen receptor CAR T cell immunotherapies: Maryland Monday, June 30, 2025, 13:00 Hrs [IST] The US Food and Drug Administration (FD ...

The FDA has removed the REMS program requirement for currently approved BCMA- and CD19-directed autologous CAR T-cell therapies.

The agency stated that REMS requirements can be removed because safety and effectiveness are assured without them.

The FDA has removed Risk Evaluation and Mitigation Strategies (REMS) for approved chimeric antigen receptor (CAR) T-cell therapies for hematologic malignancies, aiming to ease provider burden and ...

Previously, due to the risk of cytokine release syndrome and neurological toxicities, many CAR T-cell therapies included a REMS requirement.

FDA updates CAR T-cell therapy labels, easing monitoring requirements and expanding access for eligible patients in oncology.

Specifically, the FDA removed the Risk Evaluation and Mitigation Strategy (REMS) program requirements from two BCMA-directed CAR T-cell therapies for multiple myeloma — ciltacabtagene autoleucel ...

The Breyanzi REMS program and the Abecma REMS program were established due to the risk of cytokine release syndrome and neurologic toxicities.

Cell and gene therapy leaders say the agency’s decision to remove the Risk Evaluation and Mitigation Strategies that had been ...

The FDA has approved updated labels for Breyanzi and Abecma, removing the REMS programs and reducing certain restrictions.

FDA eliminated REMS for six approved CAR-T therapies. Patients no longer need to stay near treatment site for two weeks or avoid driving post-therapy. Market-moving news hits Benzinga Pro first—get a ...

Label changes remove Risk Evaluation and Mitigation Strategy programs and eases monitoring requirements, supporting broader ...