EU approves Poteligeo for 2 forms of cutaneous T-cell lymphoma.- Kyowa Hakko Kirin.
Kyowa Hakko Kirin has received marketing authorisation in Europe for use of Poteligeo (mogamulizumab) to treat Mycosis Fungoides and S�zary Syndrome, the two most common subtypes of cutaneous T-cell lymphoma, a rare type of non-Hodgkin�s lymphoma. The drug is a humanised monoclonal antibody directed against CC chemokine receptor 4 to treat adult patients with mycosis fungoides or S�zary syndrome who have received at least one prior systemic therapy.
The approval is based on a recent Phase III trial, in which the immunotherapy showed significantly superior progression-free survival than vorinostat, demonstrating a median of 7.7 months versus to 3.1 months, respectively. Kyowa Kirin plans to launch Poteligeo in Europe from 2019, and it will be the first biologic agent targeting CCR4 to be available in the region.