Lisocabtagene maraleucel granted priority review by the FDA for R/R MZL

On August 5, 2025, the U.S. Food and Drug Administration (FDA) granted priority review to the supplemental biologics license application (sBLA) for lisocabtagene maraleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adult patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who have received ≥2 prior lines of therapy.¹ 

This application is based on results from the MZL cohort (N = 67) in the phase II TRANSCEND FL trial (NCT04245839), which were presented during the 18th International Conference on Malignant Lymphoma (ICML), June 17–21, 2025, Lugano, CH.¹ Among efficacy evaluable patients (n = 66), the overall response rate was 95.5%, with a complete response rate of 62.1%.² The 24-month rates for duration of response, progression-free survival, and overall survival were 88.6%, 85.7%, and 90.4%, respectively.² Cytokine release syndrome and neurological events occurred in 76% and 33% of patients, respectively (Grade 3, 4% and 4%, respectively).² 

Lisocabtagene maraleucel has been previously approved by the FDA for the treatment of patients with R/R diffuse large B-cell lymphoma after ≥1 prior line of therapy, and R/R chronic lymphocytic leukemia/small lymphocytic lymphoma, R/R follicular lymphoma, and R/R mantle cell lymphoma, all after ≥2 prior lines of therapy.¹