The US Food and Drug Administration has approved lisocabtagene maraleucel (liso-cel; Breyanzi), a CD19-directed CAR T-cell therapy, for adult patients with relapsed or refractory marginal zone lymphoma after at least two prior lines of systemic therapy. Liso-cel is now the only CAR T-cell therapy approved for five different blood cancers, according to BMS, the drug’s manufacturer.
In the MZL cohort of the phase 2 TRANSCEND FL study, patients with relapsed or refractory disease responded strongly to a single infusion of liso-cel. The overall response rate was 95.5% and the complete response rate was 62.1%. Median duration of response was not reached, with 90.1% of responders remaining in response at 24 months. The side-effect profile matched what doctors already know from liso-cel’s use in other lymphomas, according to a press release by BMS.
