Overview
Multiple myeloma is a cancer where plasma cells rapidly divide out of control. These cancerous cells generally express the B-cell maturation antigen, while it is rarely expressed on non-cancerous cells. Multiple myeloma is typically treated with an immunomodulatory agent like lenalidomide, a proteasome inhibitor like bortezomib, or an anti-CD38 monoclonal antibody like isatuximab. Idecabtagene vicleucel, also known as bb2121, is a chimeric antigen receptor (CAR) T-cell therapy like axicabtagene ciloleucel and brexucabtagene autoleucel. These therapies involve extracting and genetically manipulating T-cells from a patient to express a CAR for a tumor specific antigen. The chimeric antigen receptor of idecabtagene vicleucel includes an anti-B-cell maturation antigen scFv-targeting domain, CD3ζ T-cell activation domain, and 4-1BB costimulatory domain. Idecabtagene vicleucel is indicated as a fifth line treatment of adult patients with relapsed or refractory multiple myeloma. Idecabtagene vicleucel was granted FDA approval on 26 March 2021.
Background
Multiple myeloma is a cancer where plasma cells rapidly divide out of control. These cancerous cells generally express the B-cell maturation antigen, while it is rarely expressed on non-cancerous cells. Multiple myeloma is typically treated with an immunomodulatory agent like lenalidomide, a proteasome inhibitor like bortezomib, or an anti-CD38 monoclonal antibody like isatuximab. Idecabtagene vicleucel, also known as bb2121, is a chimeric antigen receptor (CAR) T-cell therapy like axicabtagene ciloleucel and brexucabtagene autoleucel. These therapies involve extracting and genetically manipulating T-cells from a patient to express a CAR for a tumor specific antigen. The chimeric antigen receptor of idecabtagene vicleucel includes an anti-B-cell maturation antigen scFv-targeting domain, CD3ζ T-cell activation domain, and 4-1BB costimulatory domain. Idecabtagene vicleucel is indicated as a fifth line treatment of adult patients with relapsed or refractory multiple myeloma. Idecabtagene vicleucel was granted FDA approval on 26 March 2021.
Indication
Idecabtagene vicleucel is indicated to treat adult patients with relapsed or refractory multiple myeloma who have tried at least 4 other lines of therapy, including an immunomodulatory agent, proteasome inhibitor, and anti-CD38 monoclonal antibody.
Associated Conditions
- Refractory Multiple Myeloma
- Relapsed Multiple Myeloma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/03 | N/A | Recruiting | St. Olavs Hospital | ||
2024/11/21 | N/A | Recruiting | |||
2024/04/10 | N/A | Recruiting | |||
2023/12/04 | N/A | Active, not recruiting | |||
2023/09/21 | Phase 3 | Active, not recruiting | |||
2021/04/22 | Phase 1 | Completed | |||
2018/07/26 | Phase 2 | Active, not recruiting | |||
2017/12/05 | Phase 2 | Completed |
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 |
|---|---|---|---|
Authorised | 8/18/2021 | ||
Authorised | 8/18/2021 |
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. | |||||