FDA Approves Bristol Myers Squibb’s CAR T-Cell Therapy for Relapsed/Refractory Marginal Zone Lymphoma

WASHINGTON D.C. — December 9, 2025

The U.S. Food and Drug Administration (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). The new indication targets adult patients with relapsed/refractory (r/r) marginal zone lymphoma (MZL) who have previously received at least two lines of systemic therapy.

The FDA’s decision was based on results from the r/r MZL cohort of the Phase 2 TRANSCEND FL clinical trial. The approval solidifies Breyanzi’s standing as one of the most broadly approved CAR-T therapies for B-cell malignancies.

Data Shows High, Durable Response Rates

Data presented earlier this year at the 2025 International Conference on Malignant Lymphoma (ICML) in Switzerland highlighted the therapy’s potent and lasting effect. Among the 66 efficacy-evaluable patients with r/r MZL treated with liso-cel, the Overall Response Rate (ORR) was 95.5% and the Complete Response (CR) rate was 62.1%.

Furthermore, the therapy demonstrated durable responses, with the 24-month rate for duration of response reaching 88.6%, the 24-month rate for progression-free survival at 85.7%, and the 24-month rate for overall survival at 90.4%.

“Liso-cel achieved high, lasting response rates in patients with R/R MZL, underscoring the potential of this one-time therapy to significantly improve patient outcomes,” stated TRANSCEND FL study investigator M. Lia Palomba, M.D., in a June 2025 statement. The MZL patient population, with a median survival of only three to five years after multiple relapses, has an urgent need for transformative therapies.

Regulatory Context

The supplemental biologics license application (sBLA) for liso-cel was accepted by the FDA with Priority Review in August 2025.

Breyanzi, which is manufactured from the patient’s own T-cells, has a recommended dose constituting 90 to 110 x 10^6 CAR-positive viable T-cells. The therapy’s prescribing information includes standard boxed warnings for CAR-T treatments, such as cytokine release syndrome and neurologic toxicities.

The CAR-T product has previously received FDA approvals for a range of other hematologic malignancies, including large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma.