Kyowa Hakko Kirin, a Japanese pharmaceutical company, recently announced that the European Commission (EC) has approved Poteligeo (mogamulizumab) to treat adult patients with relapsed or refractory mycosis fugoides (MF) or Sezary syndrome (SS) who have previously received at least one systemic therapy.
This approval made Poteligeo the first biologic agent to target CC chemokine receptor 4 (CCR4). In the United States, Poteligeo was approved by the FDA for treatment of the above indications in early August this year, which is the first FDA approved drug for SS, and also provides more treatment options for MF patients.
MF and SS are the two most common subtypes of cutaneous T-cell lymphoma (CTCL), a rare non-Hodgkin’s lymphoma characterized by CCR4-related malignant T lymphocytes localized to the skin, which may affect the skin, blood, lymph nodes and internal organs in terms of different stages.
Poteligeo is a humanized monoclonal antibody that targets CCR4, which is frequently expressed on leukemia cells of certain hematological malignancies, including CTCL. Poteligeo was developed using the Potelligent platform to reduce fucose composition of carbohydrate chains of antibodies, thereby enhancing antibody-dependent cellular cytotoxicity (ADCC).
This approval applies to 28 EU member states as well as Norway, Iceland and Liechtenstein, and will be launched in European market in 2019.