CAMPATH
CAMPATH (alemtuzumab) is a CD52-directed cytolytic antibody. It is indicated as a single-agent therapy for the treatment of patients with B-cell chronic lymphocytic leukemia (B-CLL). The medication provides a targeted approach for managing this malignancy by focusing on specific immune cell populations.
How CAMPATH Works
Alemtuzumab binds to CD52, an antigen located on the surface of B and T lymphocytes, monocytes, macrophages, and natural killer cells. It also targets a proportion of bone marrow cells that express variable levels of this antigen. Following cell surface binding to leukemic cells, the drug induces antibody-dependent cellular-mediated lysis, leading to the destruction of the targeted cells.
Details
- Status
- Prescription
- First Approved
- 2001-05-07
- Routes
- INTRAVENOUS
- Dosage Forms
- VIAL
CAMPATH Approval History
What CAMPATH Treats
1 indicationsCAMPATH is approved for 1 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- B-Cell Chronic Lymphocytic Leukemia
CAMPATH Boxed Warning
CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS See full prescribing information for complete boxed warning. Serious, including fatal, cytopenias, infusion-related reactions, and infections can occur (5.1–5.3). Limit doses to 30 mg (single) and 90 mg (cumulative weekly); higher doses increase risk of pancytopenia. ( 2.1 ) Escalate dose gradually and monitor patients during infusion. Withhold therapy for Grade 3 or 4 infusion-...
WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS See full prescribing information for complete boxed warning. Serious, including fatal, cytopenias, infusion-related reactions, and infections can occur (5.1–5.3). Limit doses to 30 mg (single) and 90 mg (cumulative weekly); higher doses increase risk of pancytopenia. ( 2.1 ) Escalate dose gradually and monitor patients during infusion. Withhold therapy for Grade 3 or 4 infusion-related reactions. ( 5.2 ) Administer prophylaxis against Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections. ( 2.2 , 5.3 ) Cytopenias : Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving CAMPATH. Single doses of CAMPATH greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia [see Warnings and Precautions (5.1) ] . Infusion-Related Reactions : CAMPATH administration can result in serious, including fatal, infusion-related reactions. Carefully monitor patients during infusions and withhold CAMPATH for Grade 3 or 4 infusion-related reactions. Gradually escalate CAMPATH to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days [see Dosage and Administration (2.1) and Warnings and Precautions (5.2) ] . Immunosuppression/Infections : Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur in patients receiving CAMPATH. Administer prophylaxis against Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections [see Dosage and Administration (2.2) and Warnings and Precautions (5.3) ] .
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CAMPATH FDA Label Details
ProIndications & Usage
FDA Label (PDF)CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). CAMPATH is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).
WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS See full prescribing information for complete boxed warning. Serious, including fatal, cytopenias, infusion-related reactions, and infections can occur (5.1–5.3). Limit dos...
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.