Summary of Breyanzi:
The only CAR T-cell therapy licensed for 6 different LBCL histologies1
*Recommended by NICE only if an ASCT would be considered suitable.2
Breyanzi is indicated for the treatment of adult patients with:1
- Diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large Bcell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy
- Relapsed or refractory DLBCL, PMBCL and FL3B, after two or more lines of systemic therapy
- Relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy
- Relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor
Considerations for CAR T Referral
CAR T-cell therapy may be the next step for eligible LBCL patients when they:4,5,6
- Are refractory to 1L treatment*
- Show signs of relapse† within 12 months of completion of 1L treatment†
Who may be eligible for CAR T-cell therapy‡6
- Patients aged ≥18 years PS 0 or 1
- Sufficient end organ function to tolerate CAR T-cell therapy
Contact a CAR T treatment centre to discuss your patient's health status further
What’s next for eligible patients?
- Refer to CAR T centre
BREYANZI is recommended by NICE as an option for treating LBCL that is refractory to, or has relapsed within 12 months after, first-line chemoimmunotherapy in adults with:2
- DLBCL
- HGBCL
- PMBCL, or
- FL3B
It is recommended only if an autologous stem cell transplant would be considered suitable.2
*Refractory disease is defined as progressive disease as the best response to 1st line standard chemo-immunotherapy after at least 2 cycles of chemo-immunotherapy or stable disease as the best response after at least 4 cycles of 1st line standard chemo-immunotherapy or a partial response as the best response after at least 6 cycles of 1st line standard chemo-immunotherapy with biopsy proven residual disease or a partial response with biopsy-proven progressive disease within 12 months or less from completion of treatment. Progressive disease should be defined radiologically as per RECIST version 1.1 and be based on CT or MR scans and aided if necessary, after discussion at the National CAR T Clinical Panel, with the use of Lugano lymphoma response criteria.6
†Relapsed disease is defined as disease that was in complete remission following 1st line standard chemo-immunotherapy and has been followed by a biopsy-proven disease relapse within 12 months or less from completion of treatment.6
‡This is not a comprehensive or definitive list of eligibility criteria for CAR T therapy. Patient selection should be based on a case-by-case evaluation.
Mechanism of Action1
BREYANZI is a CD19-directed genetically modified autologous cellular immunotherapy
Targeting domain: anti-CD19
Costimulatory domain: 4-1BB
T-cell activation domain: CD3z
- Autologous T cells are transduced with a lentiviral vector encoding a CAR specific for CD19
- CD8+ and CD4+ CAR-positive T-cell components are infused in a ~1:1 ratio
- The CAR-expressing T cells bind to CD19 on the surface of B cells
Recognition and binding of the CAR to CD19 results in:
- Activation and proliferation of CAR T cells
- Release of pro-inflammatory cytokines
- Cytotoxic killing of target cells.
Overview of the BREYANZI Manufacturing Process
BMS is committed to making BREYANZI available to as many patients as possible, and has made significant investments and progress in manufacturing.
Abbreviations
1L, first-line, 3L, third line, CAR, chimeric antigen receptor, CAR T, chimeric antigen receptor T-cell, CD3/4/8/19, cluster of differentiation 3/4/8/19, DLBCL, diffuse large B-cell lymphoma, FL, follicular lymphoma, FL3B, follicular lymphoma grade 3B, LBCL, large B-cell lymphoma, LTFU, long-term follow-up, PMBCL, primary mediastinal large B-cell lymphoma,
References
- BREYANZI® (lisocabtagene maraleucel) UK Summary of Product Characteristics. Available at https://www.medicines.org.uk/emc/product/100499/smpc.
- NICE TA1048. 26 March 2025. Available at https://www.nice.org.uk/guidance/TA1048.
- NICE GID-TA11823. Available at https://www.nice.org.uk/guidance/indevelopment/gid-ta11823
- Gisselbrecht C, et al. J Clin Oncol. 2010;28(27):4184–90.
- Kamdar M, et al. Lancet. 2022;399(10343):2294–308; and supplementary appendix.
- National Cancer Drugs Fund List, 8 January 2026. Available at https://www.england.nhs.uk/publication/national-cancer-drugs-fund-list/.
2009-GB-2600118 | August 2026