Obecabatagene autoleucel

CAR-Ts, the first of which were initially approved in June 2025, have demonstrated a wealth of efficacy in haematological oncology indications. Credit: Nemes Laszlo via Shutterstock. 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. 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. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence A 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. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Navigating cell therapy process development The cell therapy manufacturing sector is rapidly evolving, driven by the need to balance innovative process development with rigorous GMP standards. 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The FDA expects that the REMS elimination and reduced post-infusion restrictions will help improve access to CAR-T therapies, particularly for patients who live in rural areas. Restricted availability under an FDA-mandated drug safety program has limited the reach of CAR-T cell therapies for certain blood cancers—until now.The FDA has removed the Risk Evaluation and Mitigation Strategies (REMS) requirements for currently approved BCMA- and CD19-directed CAR-T therapies, the agency said Thursday.Existing commercial CAR-T products, including Bristol Myers Squibb’s Abecma and Breyanzi, Gilead Sciences’ Yescarta and Tecartus, Johnson & Johnson and Legend Biotech’s Carvykti, and Novartis’ Kymriah, stand to benefit from the update. Autolus’ CD19 CAR-T Aucatzyl was approved in November for B-cell precursor acute lymphoblastic leukemia without a REMS requirement. The FDA’s website only has updated prescribing information for Carvykti as of publication time, but the agency's announcement said the REMS requirements have been removed for all these drugs.The FDA previously required the REMS safety program for each approved CAR-T drug because of the risk of cytokine release syndrome and neurological toxicities associated with the drugs.Under the REMS program, hospitals and clinics had to be be specially certified to be able to administer CAR-T therapies.Now, though, the FDA has determined that the demand is no longer necessary “[g]iven the established management guidelines and extensive experience of the medical hematology/oncology community in diagnosing and managing” the safety risks, according to an FDA approval letter (PDF) for Carvykti.Post-treatment monitoring of patients no longer has to be carried out at certified healthcare facilities, according to the FDA. In addition, patients are now asked to remain within close proximity of a healthcare facility for two weeks, rather than the previously mandated four weeks.Previously, patients were instructed to refrain from driving for at least eight weeks following infusion. Now, the new labels have shortened that period to two weeks.“These changes should facilitate patient access, particularly for those who do not live near centers of excellence where CAR-Ts are commonly administered,” Citi analysts wrote in a Friday note.“FDA expects that the REMS elimination, and these labeling 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 said in its announcement.Following the FDA’s move, BMS said it has launched “a renewed effort to add community cancer centers nationwide to administer Breyanzi and Abecma closer to patients, helping further reduce travel time and duration of stay away from home, family and work.” In a statement to Fierce Pharma, Gilead said the update “underscores the knowledge and experience that CAR T treaters have gained to safely administer these therapies,” and that the company is pleased the change “will help lessen the burden on HCPs and patients, enabling more people to receive these potentially curative treatments.”  The REMS requirements were a major burden that discouraged referrals from community doctors and affected patients’ willingness to receive a CAR-T drug, Leerink Partners analysts wrote in their own Friday note, citing two blood cancer experts. One expert told Leerink that he would expect reduced monitoring requirements and driving restrictions would double the current uptake of CAR-T therapies.The revisions are especially beneficial to the CD19 lymphoma CAR-T meds because their market penetration has remained stagnant at about 20% for some time, the Leerink analysts noted.The removal of the REMS programs in their entirety follows an FDA decision last year to eliminate requirements for educational and training materials, as well as a mandate to report adverse events suggestive of CRS or neurological toxicities, specifically under REMS. The move represents a positive sign of some regulatory continuity at the FDA’s cell and gene therapy department since the installment of several new leaders, including the new Center for Biologics Evaluation and Research (CBER) director, Vinay Prasad, M.D., and the reported sudden ouster of Nicole Verdun, M.D., director of the Office of Therapeutic Products within CBER last week. While the REMS items are gone, the CAR-T products’ labels still carry black box warnings about CRS, neurotoxicity and secondary T-cell malignancies. During an interview last fall, then-CBER Director Peter Marks, M.D., Ph.D., told Fierce that the agency was reevaluating the classwide secondary cancer warnings that were recently slapped on CAR-T therapies’ labels.