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Lisocabtagene maraleucel granted approval by the EC for patients with R/R MCL
On November 25, 2025, the European Commission (EC) approved 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) mantle cell lymphoma (MCL) after ≥2 prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor (BTKi).1
This approval is based on results from the MCL cohort of the multicenter, open-label, phase I TRANSCEND-NHL-001 trial (NCT02631044).1 Among patients in the third-line setting or beyond:
- The overall response rate (ORR) and complete response (CR) rates were 82.7% and 71.6%, respectively.1
- The median time to first response was 0.95 months, with 50.8% of patients still in response at 24 months.1
- The safety profile was consistent with the known safety profile of liso-cel.1
- The majority of cases of cytokine release syndrome (CRS) and neurologic toxicities occurred within the first 14 days post-infusion.1
- Any-grade CRS and neurologic toxicities occurred in 61% and 31% of patients with MCL, respectively, with Grade 3/4 events occurring in 1% and 9% of patients, respectively.1
This expanded approval follows prior EC approval of liso-cel for adult patients with R/R diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma Grade 3B (FL3B) who relapse after 12 months or are refractory to first-line chemoimmunotherapy; for adult patients with R/R DLBCL, PMBCL, and FL3B after ≥2 lines of systemic therapy; and for adult patients with R/R follicular lymphoma (FL) after ≥2 prior lines of systemic therapy.1
Liso-cel is also approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with R/R large B-cell lymphoma (LBCL) after ≥1 prior lines of therapy; has received accelerated approval for the treatment of patients with R/R chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after ≥2 prior lines of therapy and R/R FL after ≥2 prior lines of therapy; and is approved for the treatment of R/R MCL after ≥2 prior lines of therapy.1
References
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In your experience, does lisocabtagene maraleucel offer a durable, potentially curative remission with a one-time infusion in second-line large B-cell lymphoma?
