Overview
Axicabtagene ciloleucel is an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy. The drug has a unique mechanism of action, as it utilizes the patient's own T cells, which play a central role in immune response to cancer. Once T-cells are collected from the patient, they are genetically engineered to express anti-CD19 CARs that recognize and kill cancer cells, and are infused back into the patient. Each dose of axicabtagene ciloleucel represent the patient's genetically modified T-cells. The development of resulted from early preclinical studies conducted by a group of researchers at the National Cancer Institute (NCI), who demonstrated that T cells expressing an anti-CD19 CAR can produce cytokines that efficiently kill leukemic cells in vitro. Axicabtagene ciloleucel was approved by the FDA on October 18th, 2017. It is marketed under the brand name Yescarta and is used to treat large B-cell lymphomas and follicular lymphoma in adults. Axicabtagene ciloleucel was later approved by the EMA on August 23, 2018.
Background
Axicabtagene ciloleucel is an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy. The drug has a unique mechanism of action, as it utilizes the patient's own T cells, which play a central role in immune response to cancer. Once T-cells are collected from the patient, they are genetically engineered to express anti-CD19 CARs that recognize and kill cancer cells, and are infused back into the patient. Each dose of axicabtagene ciloleucel represent the patient's genetically modified T-cells. The development of resulted from early preclinical studies conducted by a group of researchers at the National Cancer Institute (NCI), who demonstrated that T cells expressing an anti-CD19 CAR can produce cytokines that efficiently kill leukemic cells in vitro. Axicabtagene ciloleucel was approved by the FDA on October 18th, 2017. It is marketed under the brand name Yescarta and is used to treat large B-cell lymphomas and follicular lymphoma in adults. Axicabtagene ciloleucel was later approved by the EMA on August 23, 2018.
Indication
In the US, axicabtagene ciloleucel is indicated for the treatment of adults with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. In the US and Europe, it is used to treat adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Axicabtagene ciloleucel is also used to treat adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy in the US, or three or more lines of systemic therapy in Europe.
Associated Conditions
- Refractory Diffuse Large B Cell Lymphoma (DLBCL)
- Refractory Follicular Lymphoma
- Refractory Large B-cell Lymphoma
- Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
- Relapsed Diffuse Large B-cell Lymphoma (DLBCL)
- Relapsed Follicular Lymphoma
- Refractory High Grade B-cell Lymphoma (HGBCL)
- Relapsed High Grade B-cell Lymphoma (HGBCL)
- Relapsed Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/20 | Not Applicable | Not yet recruiting | |||
2025/03/03 | Phase 2 | Not yet recruiting | |||
2025/02/19 | Phase 2 | Recruiting | |||
2025/02/13 | Phase 2 | Recruiting | |||
2025/02/07 | Phase 1 | Recruiting | City of Hope Medical Center | ||
2025/01/20 | Phase 2 | Recruiting | |||
2024/09/24 | Phase 4 | Recruiting | N/A | ||
2024/08/12 | Phase 2 | Recruiting | Marcela V. Maus, M.D.,Ph.D. | ||
2024/01/19 | Phase 2 | Recruiting | |||
2023/10/27 | Phase 2 | 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 |
|---|---|---|---|
Authorised | 8/23/2018 | ||
Authorised | 8/23/2018 |
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 |
|---|---|---|---|---|---|
| Axicabtagene Ciloleucel Injection | 国药准字S20210019 | 生物制品 | 注射剂 | 6/22/2021 |
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 |
|---|---|---|---|---|---|
| T Cells - Axicabtagene ciloleucel, cryopreserved - T - Yescarta | 400895 | Biological | A | 12/12/2022 |