Summary
The FDA has granted Priority Review to Breyanzi for relapsed or refractory marginal zone lymphoma, with a PDUFA date of December 5, 2025. Backed by Phase II TRANSCEND FL data showing a 95.5% overall response rate and 62.1% complete response rate, Breyanzi continues to demonstrate durable efficacy and safety in third-line+ MZL. The acceptance of this sBLA signals growing regulatory momentum for CAR T therapies in indolent lymphomas and highlights the importance of single-arm trial designs in rare, relapsed populations.
The FDA has accepted Bristol Myers Squibb’s (BMS) supplemental biologics license application (sBLA) for Breyanzi (lisocabtagene maraleucel; liso-cel) as a potential therapy for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. The application has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) date of December 5, 2025.1
Priority Review follows strong results from TRANSCEND FL
Breyanzi’s sBLA for relapsed or refractory MZL is based on positive results from the Phase II TRANSCEND FL (NCT04245839) clinical trial, which BMS presented data from at the 2025 International Conference on Malignant Lymphoma (ICML) earlier in June.2
In a press release, Rosanna Ricafort, vice president, senior global program lead for hematology and cell therapy, BMS, said: “While initial therapy for MZL can be effective, multiple relapses over the course of several years are common, leaving patients in need of a new treatment option that can provide high, lasting response rates. This FDA acceptance brings us one step closer to potentially standardizing CAR T cell therapy as a treatment option for MZL, while building on our commitment to bring this personalized therapy to as many eligible patients as possible.”
Breyanzi delivers 95.5% response rate in MZL
The primary analysis of the MZL cohort from TRANSCEND FL, which included adults with relapsed or refractory disease who were administered Breyanzi in the third-line plus setting at a target dose of 100 x 106 CAR-positive viable T cells, showed a strong efficacy and durable response.
- In a cohort of 66 efficacy-evaluable patients with relapsed or refractory marginal zone lymphoma, Breyanzi achieved an objective response rate of 95.5% (95% CI: 87.3–99.1; one-sided p<0.0001).
- Complete responses (CRs) were observed in 62.1% of patients, as assessed by an independent review committee (95% CI: 49.3–73.8; one-sided p<0.0001).
- The duration of response (DoR) was 88.6% at a median follow-up of 21.6 months.
- Progression-free survival (PFS) was 85.7% at a median follow-up of 23.8 months.
- Overall survival reached 90.4% at a median follow-up of 24.5 months.
In a press release from the time of when the MZL TRANSCEND FL data were shared, M. Lia Palomba, MD, TRANSCEND FL study investigator and lymphoma and cell therapy specialist, Memorial Sloan Kettering Cancer Center, said: “Liso-cel achieved high, lasting response rates in patients with relapsed or refractory marginal zone lymphoma, underscoring the potential of this one-time therapy to significantly improve patient outcomes. Currently, the median survival for patients with marginal zone lymphoma with multiple relapses is 3 to 5 years, signifying an urgent need for transformative therapies that can effectively address this hard-to-treat disease.”3
TRANSCEND FL evaluates Breyanzi in indolent B-cell lymphoma
TRANSCEND FL is an open-label, single-arm trial conducted at multiple global sites.
- The study is evaluating the efficacy and safety of Breyanzi in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma.
- Eligible subtypes include follicular lymphoma and MZL.
- The primary endpoint is overall response rate.
- Secondary endpoints include complete response rate, DoR, and PFS.
Breyanzi previously approved for mantle cell lymphoma
Breyanzi’s latest FDA approval came in May 2024 for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL) who were previously administered at least two lines of systemic therapy that included a Bruton tyrosine kinase inhibitor. This approval was based on data from the MCL cohort of the open-label, multicenter, TRANSCEND NHL 001 (NCT02631044) study.4
Results from TRANSCEND NHL 001 showed 85.3% (95% CI: 74.6-92.7) of patients who received Breyanzi and were evaluated for efficacy responded to treatment and 67.6% (95% CI: 55.2-78.5) achieved a CR.
References
1. Bristol Myers Squibb’s Application for Breyanzi (lisocabtagene maraleucel) Accepted for Priority Review by U.S. Food and Drug Administration (FDA) in Fifth Cancer Type for Relapsed or Refractory Marginal Zone Lymphoma (MZL). News release. Bristol Myers Squibb. August 4, 2025. Accessed August 5, 2025. https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibbs-Application-for-Breyanzi-lisocabtagene-maraleucel-Accepted-for-Priority-Review-by-U-S--Food-and-Drug-Administration-FDA-in-Fifth-Cancer-Type-for-Relapsed-or-Refractory-Marginal-Zone-Lymphoma-MZL/default.aspx
2. Phase II TRANSCEND FL Shows Breyanzi Achieves Strong Efficacy, Durable Response in Relapsed Marginal Zone Lymphoma. Applied Clinical Trials. June 19, 2025. Accessed August 5, 2025. https://www.appliedclinicaltrialsonline.com/view/breyanzi-relapsed-marginal-zone-lymphoma
3. Bristol Myers Squibb Presents First Data from the Marginal Zone Lymphoma Cohort of the Transcend FL Trial Demonstrating Deep and Durable Responses with Breyanzi (lisocabtagene maraleucel). News release. June 16, 2025. Accessed August 5, 2025. https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Presents-First-Data-from-the-Marginal-Zone-Lymphoma-Cohort-of-the-Transcend-FL-Trial-Demonstrating-Deep-and-Durable-Responses-with-Breyanzi-lisocabtagene-maraleucel/default.aspx
4. Breyanzi Gets FDA Approval to Treat Relapsed/Refractory Mantle Cell Lymphoma. Applied Clinical Trials. May 31, 2024. Accessed August 5, 2025. https://www.appliedclinicaltrialsonline.com/view/breyanzi-gets-fda-approval-to-treat-relapsed-refractory-mantle-cell-lymphoma
