EU approves Kyowa Kirin’s drug for rare lymphoma

The European Commission has approved Poteligeo (mogamulizumab), a treatment for rare types of non-Hodgkin’s lymphoma. The drug is manufactured by Japanese firm Kyowa Hakko Kirin (Kyowa Kirin) and is for adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy. Poteligeo is a humanized monoclonal antibody, which acts against the against CC chemokine receptor 4 (CCR4), which is often found in the cells of patients with certain haematologic malignancies including CTCL (cutaneous T-cell lymphoma).
The treatment is the first biologic available to patients in Europe who have MF or SS. Approval was based on the results of a phase 3 trial in which Poteligeo demonstrated a median progression-free survival (PFS) of 7.7 months compared with 3.1 months for those prescribed histone deacetylase (HDAC) inhibitor vorinostat. Tom Stratford, CEO of Kyowa Kirin International, said: “Mycosis fungoides and Sézary syndrome are horrible conditions which patients literally wear on their skin.