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.
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
Research Report
A Comprehensive Monograph on Alemtuzumab: From Molecular Design to Clinical Application and Risk Management
Executive Summary
Alemtuzumab is a biotherapeutic agent that stands as a paradigm of modern medicine's capacity to achieve profound clinical efficacy, a benefit that is inextricably linked to a significant and complex risk profile. This report provides an exhaustive analysis of alemtuzumab, tracing its journey from a laboratory tool to its dual, divergent identities in clinical practice: as Campath for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) and as Lemtrada for relapsing forms of multiple sclerosis (MS). Its core mechanism of action is the targeting of the CD52 glycoprotein, which is highly expressed on mature lymphocytes. This interaction induces a rapid, profound, and prolonged lymphopenia, effectively constituting an "immune system reset".[1]
In both of its approved indications, alemtuzumab has demonstrated superior efficacy against active comparators. In CLL, it produced significantly higher response rates and longer progression-free survival than chlorambucil, particularly in patients with high-risk cytogenetics.[4] In MS, it proved more effective than interferon beta-1a at reducing relapse rates and, in previously treated patients, at slowing or even improving disability, offering the prospect of durable remission in the absence of continuous therapy.[6]
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 |
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 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
LEMTRADA | sanofi-aventis canada inc | 02418320 | Solution - Intravenous | 12 MG / 1.2 ML | 1/29/2014 |
MABCAMPATH | sanofi-aventis canada inc | 02290960 | Solution - Intravenous | 30 MG / ML | 9/7/2007 |
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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