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Poteligeo
Published
Product name
Poteligeo
Active ingredient
Mogamulizumab
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Poteligeo (mogamulizumab) was approved for the following therapeutic use:
Poteligeo is indicated for the treatment of adult patients (≥ 18 years of age) with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.
How this medicine works
Mogamulizumab is a defucosylated, humanised immunoglobulin G 1 (IgG1) kappa monoclonal antibody that selectively binds to C-C motif chemokine receptor 4 (CCR4), a G protein-coupled receptor for CC chemokines that is involved in the trafficking of lymphocytes to various organs including the skin. CCR4 is expressed on the surface of some T cell malignancies, such as MF and SS as well as Type 2 T helper (Th2) T cells and regulatory T cells (Tregs). Binding of mogamulizumab to CCR4 induces antibody-dependent cellular cytotoxicity (ADCC), resulting in the depletion of target cells.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Poteligeo was considered favourable for the therapeutic use approved.
Sponsor