CHMP positive for mogamulizumab for treatment of patients with mycosis fungoides or Sezary syndrome.- Kyowa Hakko Kirin

Kyowa Hakko Kirin Co., Ltd., announced that the Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency's (EMA) scientific committee, has adopted a Positive Opinion recommending approval of the marketing authorisation of mogamulizumab, a humanised monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), for the treatment of adult patients with mycosis fungoides (MF) or Sezary syndrome (SS) who have received at least one prior systemic therapy. MF and SS are the two most common subtypes of cutaneous T-cell lymphoma (CTCL), a rare type of non-Hodgkin's lymphoma.

Comment: Mycosis fungoides, also known as Alibert-Bazin syndrome or granuloma fungoides, is the most common form of cutaneous T-cell lymphoma. It generally affects the skin, but may progress internally over time. Symptoms include rash, tumors, skin lesions, and itchy skin. While the cause remains unclear, most cases are not hereditary. Most cases are in people over 20 years of age, and it is more common in men than women. Treatment options include sunlight exposure, ultraviolet light, topical corticosteroids, chemotherapy, and radiotherapy. Sezary disease is a type of cutaneous lymphoma that was first described by Albert Sezary. The affected cells are T-cells (so it is a T-cell lymphoma) that have pathological quantities of mucopolysaccharides. Sezary disease is sometimes considered a late stage of mycosis fungoides with lymphadenopathy. There are currently no known causes of Sezary disease.