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.
Background
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)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
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 | ||
2023/01/05 | Phase 2 | Recruiting | City of Hope Medical Center | ||
2022/12/01 | Phase 2 | Recruiting | |||
2022/11/17 | Phase 1 | Recruiting |
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. | |||||