The US Food and Drug Administration (FDA) has removed the risk evaluation and mitigation strategies (REMS) requirements for all approved autologous chimeric antigen receptor (CAR-T) cell immunotherapies, saying the access barrier is no longer needed for the modality.
REMS is a safety programme that the FDA requires for certain serious safety concerns to help ensure the benefits of the medication outweigh its risks. It limits the access of approved drugs to certain hospitals and clinics that had to be specially certified for therapy administration and have access to anti-inflammatory medication.
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CAR-Ts, the first of which were initially approved in June 2025, have demonstrated a wealth of efficacy in haematological oncology indications by boosting the patients’ own T-cells to fight cancer cells. However, their use comes with the risks of cytokine release syndrome (CRS) and neurological toxicities.
The FDA commented that REMS is no longer necessary to ensure that the benefits of BCMA-directed and CD19-directed CAR-T cell immunotherapies outweigh their risks. It added that the elimination of the access barrier would minimise burden on healthcare systems.
Bristol Myers Squibb’s Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel), and Johnson & Johnson/Legend Biotech’s Carvykti (ciltacabtagene autoleucel) will have their REMS requirements removed.
Novartis’ Kymriah (tisagenlecleucel), along with Gilead Sciences’ Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel), also stand to benefit from the FDA’s decision.
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By GlobalDataA seventh FDA-approved CAR-T therapy – Autolus’ Aucatzyl (obecabtagene autoleucel) – will not be affected because it never carried a REMS requirement.
“FDA has determined that the safe and effective use of CAR T cell immunotherapies for the indicated population can be assured without a REMS. Adverse event reporting for CRS and neurological toxicity have remained stable,” the agency said in a statement.
William Blair analysts commented in a research note: “We view the removal of the REMS program for CAR-T cell therapies as a positive development for the space, as it supports the notion that the FDA is working to minimise red tape and increase access to potentially curative treatments for patients.”
The agency said that safety information can be adequately conveyed using drug product labelling. This includes a boxed warning for the risks of CRS and neurological toxicities.
A Gilead spokesperson told Pharmaceutical Technology: “This [decision] underscores the knowledge and experience that CAR-T treaters have gained to safely administer these therapies, and we are pleased that they will help lessen the burden on healthcare professionals and patients, enabling more people to receive these potentially curative treatments.”
While continuous monitoring and assessment will still be carried out by the FDA, the removal of REMS is expected to facilitate patient access and is viewed as a positive development for the sector.
“FDA expects that the REMS elimination, and these labelling updates, will help improve access to these products, particularly for patients who live in rural areas, while ensuring safe and effective administration to patients who need them,” the agency commented.
William Blair analysts agreed, saying that “the removal of the REMS requirements could increase access and use of these therapies in the community settings”.
“This update also suggests we may not see REMS requirements for CD19 and BCMA autologous CAR-T cell therapies in the future,” the research note added.
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