FDA eliminates REMS for approved CAR-T therapies

The US Food and Drug Administration (FDA) has announced that six approved autologous chimeric antigen receptor T-cell (CAR-T) immunotherapies will no longer be required to comply with risk evaluation and mitigation strategies (REMS) reporting requirements. This decision is based on a better understanding of these products since their initial approval in 2017.

The REMS elimination means that hospitals and clinics that dispense these products do not have to have onsite, immediate access to tocilizumab. The action also means less restrictive labeling for these products. Under the REMS, patients were required to remain near a treatment center for four weeks and were prohibited from driving for eight weeks after treatments. The new labeling requires that patients be near a healthcare facility for two weeks and that healthcare personnel advise patients to avoid driving for two weeks following administration.

REMS will no longer be required for Bristol Myers Squibb’s Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel); Johnson and Johnson’s Carvykti (ciltacabtagene autoleucel); Novartis’s Kymriah (tisagenlecleucel); Gilead’s Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel)

Vinay Prasad, director of the FDA Center for Biologics Evaluation and Research (CBER), called the action a "bold step," and added that REMS are a “useful safety system,” but stressed the need for a reevaluation to determine if REMS for these products were still necessary.

This action “expedites the delivery of potentially curative treatments to patients and reduces burden on providers,” Prasad said.

The agency stated that these actions will enhance access to these products, especially for patients residing in rural areas, while ensuring safe and effective administration for those who need them.

FDA has stated that the medical community's extensive experience in managing the risks associated with cytokine release syndrome (CRS) and neurological toxicities linked to autologous CAR-T cell immunotherapies has rendered the use of REMs unnecessary. Furthermore, reports of adverse events related to CRS and neurological toxicity have remained consistent.

Instead, the information about the risks associated with CAR-T cell immunotherapies can be effectively communicated through the existing product labeling. This includes a boxed warning highlighting the risks of CRS and neurological toxicities, as well as the medication guides that are part of the approved labeling.

The agency said that the removal of the REMS for these products does not alter the requirement for manufacturers to conduct postmarketing observational safety studies. These studies are intended to assess the risk of secondary malignancies and long-term safety by following patients for 15 years after administration.

Lynelle Hoch, the president of the Cell Therapy Organization for Bristol Myers Squibb, applauded this action. “CAR T cell therapy is a transformational, potentially life-saving option for patients living with blood cancers, and we are working to challenge current practices, assumptions, and barriers that limit access,” she said in a statement. “Today's FDA-approved label updates reinforce BMS’ continued efforts to collaborate across the healthcare ecosystem, with the ultimate goal of reaching more patients and democratizing access to cell therapy.”

FDA announcement

FDA eliminates REMS for approved CAR-T therapies

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