Kyowa Hakko Kirin China Pharmaceutical Co., Ltd’s mogamulizumab, a first-in-class chemokine receptor type 4 (CCR4) monoclonal antibody (mAb), has been approved by the National Medical Products Administration (NMPA) for the treatment of adult patients with recurrent or refractory Sezary syndrome (SS) or advanced (III/IV) mycosis fungoides (MF) who have previously received systemic treatment. Mycosis fungoides is a form of T-cell lymphoma where malignant lymphocytes affect the skin.
Approval Based on MAVORIC Study
The approval is based on the results of the MAVORIC study, the largest clinical trial conducted in patients with SS and MF to date. The study demonstrated that the duration of disease control in patients treated with mogamulizumab was more than twice as long as that in patients treated with the control drug vorinostat (median progression-free survival: 7.7 months vs. 3.1 months). Additionally, the response rate of mogamulizumab was higher across all disease stages compared to vorinostat. The confirmed complete remission rates were 28% for mogamulizumab and 5% for vorinostat (P<0.001). Mogamulizumab exhibited good overall tolerability and controllable safety.
Technology and Global Recognition
Mogamulizumab utilizes Kyowa Hakko Kirin’s proprietary POTELLIGENT technology, which enhances the natural immune response of the human body to the treatment, thereby improving the effectiveness in killing cancer cells. The drug has previously been awarded breakthrough therapy designation (BTD) and orphan drug designation (ODD) in the US, as well as ODD in Europe. Mogamulizumab is the first and only approved CCR4-targeted biologic product in China and other regions worldwide.-Fineline Info & Tech
