CARVYKTI delivers 5-year remissions; FDA eliminates CAR-T REMS program

At ASCO 2025, new five-year follow-up data from the CARTITUDE-1 trial highlighted the long-term efficacy of a single infusion of CARVYKTI (ciltacabtagene autoleucel) in heavily pretreated patients with relapsed/refractory multiple myeloma. Approximately 33% of patients remained progression-free at five years, with no additional anti-myeloma therapy administered after infusion. Many patients achieved and maintained minimal residual disease (MRD)-negative status, marking the deepest and longest responses recorded with any BCMA-targeted therapy to date. This outcome supports CARVYKTI's use as a potentially curative option. Complementing the efficacy data, in June 2025, the FDA officially removed the REMS programs for all approved CAR-T therapies, including CARVYKTI and Abecma, citing mature post-marketing safety data and reduced incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). The deregulation is expected to broaden access, reduce logistical burdens, and support earlier-line use. Analysts forecast increased utilization of CARVYKTI across U.S. centers and payers revisiting reimbursement models to support expansion.‍

Citation: https://www.oncologynewscentral.com/drugs/info/fda-approves-major-label-changes-for-car-t-therapies

Implication: REMS removal will ease access and broaden uptake for CAR-T therapies; long-term data solidify Carvykti's position.

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