Guess the Therapy Answer December 17, 2025

Which CAR-T product was approved by the FDA for R/R Marginal Zone Lymphoma in December 2025?

Answer: lisocabtagene maraleucel (liso-cel; marketed as Breyanzi)

See below for further reading on liso-cel:

FDA Approves BMS’s Liso-Cel for R/R Marginal Zone Lymphoma

The FDA has approved Bristol Myers Squibb’s autologous CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy lisocabtagene maraleucel (liso-cel, marketed as Breyanzi) for the treatment of relapsed/refractory (r/r) marginal zone lymphoma (MZL) in adults who have previously been treated with at least 2 lines of systemic therapy.

The agency's decision was based on results from an r/r MZL cohort in the phase 2 TRANSCEND FL clinical trial (NCT04245839), a multicenter, open-label study. The cohort included adults with r/r MZL who had previously been treated with 2 or more previous lines of systemic therapy or who had relapsed following hematopoietic stem cell transplant (HSCT) and was open to patients with an Eastern Cooperative Oncology Group performance status of 1 or lower.

Survival Outcomes Found to Be Comparable for Axi-Cel, Liso-Cel, and Tisa-Cel in Real-World DLBCL Data

In a retrospective, observational study, patients with diffuse large B-cell lymphoma (DLBCL) who were treated with tisagenlecleucel (tisa-cel; Kymriah), axicabtagene ciloleucel (axi-cel; Yescarta), or liso-cel across their FDA-approved indications did not show statistically significant differences in overall survival (OS) (log-rank test: χ², 0.773; degrees of freedom [df], 1; P = .379). The data were presented in a poster at the European Hematology Association (EHA) 2025 Congress, held June 12 to 15, both virtually and in Milan, Italy.