Lisocabtagene maraleucel receives European Commission approval for the treatment of adult patients with R/R FL

On March 17, 2025, the European Commission 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 or refractory (R/R) follicular lymphoma (FL) who progress after ≥2 lines of systemic therapy. This announcement is based on key results from the phase II TRANSCEND FL trial (NCT04245839).¹

TRANSCEND FL trial

TRANSCEND FL is an open-label, global, multicenter, phase II, single-arm trial designed to determine the efficacy and safety of liso-cel in adult patients with R/R indolent B-cell non-Hodgkin lymphoma, including FL, who received ≥2 prior lines of systemic therapy.¹

Among evaluable patients with FL¹:

• The overall response rate was 97.1% (95% CI, 91.7–99.4).
• The complete response rate was 94.2% (95% CI, 87.8–97.8).

• The 18-month duration of response rate was 75.7% (95% CI, 66.0–83.0).

• Safety data from the study were consistent with the known adverse effect profile of liso-cel and no new safety signals were identified.
• Any grade cytokine release syndrome was reported in 58% of patients (Grade 3, 0.8%).
• Any grade neurologic toxicities were reported in 16% of patients (Grade 3, 3%).

In May 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to liso-cel for the treatment of adult patients with R/R FL who have received ≥2 prior lines of systemic therapy.²