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

The FDA said risks linked to CAR-T cell therapies can be effectively communicated through existing labeling, including boxed ...

Restricted availability under an FDA-mandated drug safety program has limited the reach of CAR-T cell therapies for certain ...

The agency removed some onerous requirements for the complex cancer drugs and reduced restrictions on patients’ ...

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 ...

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 ...

Label updates have been approved by the FDA for the CAR T-cell therapies Breyanzi and Abecma in large B cell lymphoma and ...

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

The U.S. Food and Drug Administration said on Friday it had eliminated risk evaluation and mitigation strategies (REMS), a ...