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South Korea’s MFDS approves anbalcabtagene autoleucel for adults with R/R DLBCL and PMBCL

By Amy Hopkins

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Apr 30, 2026

Learning objective: After reading this article, learners will be able to cite a new clinical development in diffuse large B-cell lymphoma.


On April 29, 2026, South Korea’s Ministry of Food and Drug Safety (MFDS) approved anbalcabtagene autoleucel, a chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adults with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) after ≥2 lines of systemic therapy.1 

This approval was supported by results from a phase II trial, in which anbalcabtagene autoleucel demonstrated an objective response rate (ORR) of 75.3%, with a complete response (CR) in 67.1% of patients.1 Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were reported in 10% and 5% of patients, respectively.1 

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