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 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.

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

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 ...

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

Researchers have pioneered a novel 3D platform that mimics the human bone marrow and immune environment, enabling more ...

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

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

FDA approved label changes for Breyanzi and Abecma, easing access by reducing monitoring rules and eliminating REMS safety ...