Overview
Lisocabtagene maraleucel is a chimeric antigen receptor (CAR) T-cell therapy, similar to brexucabtagene autoleucel and axicabtagene ciloleucel. Lisocabtagene maraleucel is a genetically modified autologous T-cell therapy that targets CD19, the B-lymphocyte surface antigen B4. CAR T-cell therapy has changed the treatment of B-cell lymphomas, significantly increasing survival rates over standard therapy. However, data on the efficacy of CAR T-cell therapies on less severe forms of B-cell lymphoma are lacking. Despite the adverse reactions, the majority of patients given lisocabtagene maraleucel reported an overall increase in quality of life over a 1 year period. Lisocabtagene maraleucel was granted FDA approval on 5 February 2021 and EC approval on 5 April 2022. It was later granted Health Canada approval on 6 May 2022.
Indication
Lisocabtagene maraleucel is indicated to treat adults with relapsed or refractory large B-cell lymphoma after ≥2 systemic therapies, diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma.
Associated Conditions
- Grade 3b Follicular Lymphoma
- High-grade B Cell Lymphoma (HGBCL)
- Primary Mediastinal (Thymic) Large B Cell Lymphoma (PMBCL)
- Refractory Diffuse Large B Cell Lymphoma (DLBCL)
- Refractory Large B-cell Lymphoma
- Relapsed Diffuse Large B-cell Lymphoma (DLBCL)
Research Report
Lisocabtagene Maraleucel (Breyanzi): A Comprehensive Clinical and Scientific Monograph
Executive Summary
Lisocabtagene maraleucel (liso-cel), marketed as Breyanzi, represents a significant advancement in the field of cellular immunotherapy for B-cell malignancies. It is a second-generation, autologous, CD19-directed chimeric antigen receptor (CAR) T-cell therapy. A defining feature of its molecular design and manufacturing process is the administration of a defined composition of CD4+ and CD8+ CAR-positive T-cells at a consistent 1:1 ratio, a strategy intended to produce more predictable cellular kinetics and a manageable safety profile. The therapy has demonstrated transformative efficacy in patients with relapsed or refractory (R/R) B-cell cancers, leading to durable remissions in populations with historically poor prognoses.
Clinical development has established lisocabtagene maraleucel as a new standard of care in the second-line treatment of large B-cell lymphoma (LBCL), based on the pivotal Phase 3 TRANSFORM trial, which showed a profound improvement in event-free survival over high-dose chemotherapy and autologous stem cell transplantation. Its efficacy is further supported by the TRANSCEND NHL 001 and PILOT studies, which established its value in third-line or later LBCL and in transplant-ineligible patients, respectively. The therapeutic scope has expanded to include R/R follicular lymphoma (FL), mantle cell lymphoma (MCL), and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/09/26 | Not Applicable | Not yet recruiting | |||
2025/09/23 | Not Applicable | Not yet recruiting | |||
2025/08/01 | Not Applicable | Recruiting | |||
2025/06/11 | Phase 2 | Not yet recruiting | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | ||
2025/01/27 | N/A | Recruiting | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | ||
2025/01/23 | N/A | Recruiting | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | ||
2025/01/23 | N/A | Recruiting | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | ||
2024/04/10 | N/A | Recruiting | |||
2024/03/15 | Phase 3 | Not yet recruiting | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | ||
2023/05/24 | Phase 2 | Recruiting | Aseel Alsouqi |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| BREYANZI | bristol-myers squibb canada | 02527138 | Suspension - Intravenous | 120000000 CELLS | 11/19/2024 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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