Kyowa Hakko Kirin (Kyowa Kirin) has received marketing authorisation Europe for use of Poteligeo to treat Mycosis Fungoides and Sézary Syndrome, the two most common subtypes of cutaneous T-cell lymphoma, a rare type of non-Hodgkin’s lymphoma.
Poteligeo (mogamulizumab) is a humanised monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.
In a recent Phase III trial, the immunotherapy showed significantly superior progression-free survival (PFS) than vorinostat, with data showing a median of 7.7 months versus to 3.1 months, respectively.
Kyowa Kirin plans to launch Poteligeo in various markets in Europe from 2019, and it will be the first biologic agent targeting CCR4 to be available for patients in the region.
“With this approval, now there is a new option for the patients with MF or SS across Europe,” said Mitsuo Satoh, executive officer, vice president head of R&D Division of Kyowa Kirin.
“I’m delighted about the European Commission’s decision which is strategically important for us to realise our mid-term business plan and our goal as a global specialty pharmaceutical company.”
MF and SS are “horrible conditions which patients literally wear on their skin” according to Tom Stratford, Kyowa Kirin’s chief executive. He continued to say: “The granting of this marketing authorisation is encouraging news for those across Europe who live with these conditions every day and we look forward to making Poteligeo available for patients and clinicians across Europe.”