Overview
Alemtuzumab is a humanized monoclonal antibody specific to lymphocyte antigens. It is a recombinant DNA-derived humanized monoclonal antibody (Campath-1H) that is directed against the 21-28 kD cell surface glycoprotein, CD52. The Campath-1H antibody is an IgG1 kappa with the human variable framework and constant regions, and complementarity-determining regions from a murine (rat) monoclonal antibody (Campath-1G). Alemtuzumab is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Alemtuzumab was approved by the FDA in 2001. It is marketed as LEMTRADA for multiple sclerosis (MS) treatment and CAMPTAH for B-cell chronic lymphocytic leukemia (B-CLL). The dose of alemtuzumab used for B-CLL is much higher than that for MS, and also at more frequent dosing.
Background
Alemtuzumab is a humanized monoclonal antibody specific to lymphocyte antigens. It is a recombinant DNA-derived humanized monoclonal antibody (Campath-1H) that is directed against the 21-28 kD cell surface glycoprotein, CD52. The Campath-1H antibody is an IgG1 kappa with the human variable framework and constant regions, and complementarity-determining regions from a murine (rat) monoclonal antibody (Campath-1G). Alemtuzumab is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Alemtuzumab was approved by the FDA in 2001. It is marketed as LEMTRADA for multiple sclerosis (MS) treatment and CAMPTAH for B-cell chronic lymphocytic leukemia (B-CLL). The dose of alemtuzumab used for B-CLL is much higher than that for MS, and also at more frequent dosing.
Indication
用于烷化剂氟达拉滨（fludarabine）治疗失败的B细胞性慢性淋巴细胞白血病患者；亦可用于复发缓解型多发性硬化症治疗。
Associated Conditions
- B-Cell Chronic Lymphocytic Leukemia
- Kidney Transplant Rejection
- Relapsing Remitting Multiple Sclerosis (RRMS)
- Secondary Progressive Multiple Sclerosis (SPMS)
- Steroid Refractory Acute Graft Versus Host Disease
- T-cell Prolymphocytic Leukemia (T-PLL)
- Refractory Autoimmune Hemolytic Anemia
- Refractory Idiopathic thrombocytopenic purpura
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/11 | Phase 1 | Recruiting | |||
2025/05/07 | Phase 1 | ENROLLING_BY_INVITATION | |||
2025/03/12 | Phase 2 | Recruiting | |||
2024/11/26 | N/A | Completed | |||
2024/04/10 | Phase 2 | Recruiting | Children's National Research Institute | ||
2024/03/15 | N/A | Active, not recruiting | |||
2023/10/16 | Phase 2 | Not yet recruiting | |||
2023/06/15 | N/A | Recruiting | |||
2023/01/18 | N/A | Recruiting | |||
2022/08/15 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Genzyme Corporation | 58468-0357 | INTRAVENOUS | 30 mg in 1 mL | 4/1/2023 | |
| Genzyme Corporation | 58468-0200 | INTRAVENOUS | 12 mg in 1.2 mL | 2/21/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/12/2013 | ||
Authorised | 9/12/2013 | ||
Authorised | 9/12/2013 | ||
Authorised | 9/12/2013 | ||
Authorised | 9/12/2013 | ||
Authorised | 9/12/2013 | ||
Authorised | 9/12/2013 | ||
Authorised | 9/12/2013 | ||
Authorised | 9/12/2013 | ||
Authorised | 9/12/2013 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| LEMTRADA CONCENTRATE FOR SOLUTION FOR INFUSION 12 MG/ 1.2 ML | SIN14919P | INFUSION, SOLUTION CONCENTRATE | 12 mg/1.2 ml | 1/8/2016 |
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 |
|---|---|---|---|---|---|
| LEMTRADA alemtuzumab 10 mg/mL injection concentrated vial | 200941 | Medicine | A | 12/18/2013 | |
| MABCAMPATH alemtuzumab 30mg/mL concentrate solution for infusion vial | 116622 | Medicine | A | 5/10/2006 |