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

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

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’ ...

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

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 ...

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

FDA officials have determined that information regarding the risks for six CAR T-cell therapies can be communicated through product labeling, which includes a boxed warning for the risks of cytokine ...

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