POTELIGEO
POTELIGEO (mogamulizumab-kpkc) is a monoclonal antibody indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS). It is specifically used for cases that are relapsed or refractory following at least one prior systemic therapy. This therapy provides a targeted treatment option for patients with these specific forms of cutaneous T-cell lymphoma who have not responded to previous systemic treatments.
How POTELIGEO Works
Mogamulizumab-kpkc is a humanized monoclonal antibody that binds to CC chemokine receptor type 4 (CCR4), a protein involved in the trafficking of lymphocytes to various organs. This receptor is expressed on the surface of certain T-cell malignancies, as well as regulatory T-cells and specific Th2 T-cells. By binding to CCR4, the drug targets these cells for antibody-dependent cellular cytotoxicity, which results in the depletion of the malignant target cells.
Details
- Status
- Prescription
- First Approved
- 2018-08-08
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
POTELIGEO Approval History
What POTELIGEO Treats
2 indicationsPOTELIGEO is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Mycosis Fungoides
- Sezary Syndrome
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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.
POTELIGEO FDA Label Details
ProIndications & Usage
FDA Label (PDF)POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. POTELIGEO is a CC chemokine receptor type 4 (CCR4)-directed monoclonal antibody indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy .
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.