FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Kyowa Kirin’s Poteligeo Gains European Marketing Authorization

Dec. 11, 2018

The European Commission granted marketing authorization for Kyowa Kirin’s Poteligeo (mogamulizumab), a treatment for adults with mycosis fungoides or Sézary syndrome who have undergone at least one prior systemic therapy.

The two cancers are the most common subtypes of cutaneous T-cell lymphoma, a rare form of non-Hodgkin’s lymphoma.

Poteligeo targets CC chemokine receptor 4-expressing T-cells in the patient’s blood and skin to manage symptoms. It is the first biologic agent targeting CCR4 to be approved in Europe.

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