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

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

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 ...

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

Since the first-generation CAR-Ts reached the market several years ago, clinicians have become more adept at handling ...

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 ...

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

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 ...

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

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