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Lisocabtagene maraleucel granted approval by the FDA for patients with R/R MZL
On December 4, 2025, the U.S. Food and Drug Administration (FDA) granted approval to lisocabtagene maraleucel (liso-cel), 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) after ≥2 prior lines of systemic therapy.1 Liso-cel was previously granted priority review by the FDA for the same indication.
This approval is based on results from the MZL cohort (N = 67) in the phase II open-label, single-arm TRANSCEND FL trial (NCT04245839).1 Among efficacy evaluable patients treated in the third-line setting and beyond (n = 66), the overall response rate (ORR) was 95.5%, with the median duration of response not reached.1 The safety profile was consistent with previous reports, with any grade and Grade ≥3 cytokine release syndrome (CRS) occurring in 76% and 4.5% of patients, respectively.1
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In your experience, when do most CRS/ICANS events occur after lisocabtagene maraleucel infusion?
