Lisocabtagene maraleucel receives positive CHMP opinion for the treatment of adult patients with R/R FL

On January 31, 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of 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 trial¹

TRANSCEND FL is an open-label, global, multicenter, phase II, single-arm study 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. Among the 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.

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