Kyowa Kirin announced on October 27 that Moglizumab (trade name: Whirlpool) has been officially approved by the National Medical Products Administration (NMPA) for the treatment of relapsed or refractory patients who have received systemic therapy in the past. Adult patients with sexual Sézary syndrome (SS) or advanced (III/IV) mycosis fungoides (MF). Huilkin is the first and only CCR4-targeted biologic approved in China for the treatment of SS and MF.
Moglizumab is a first-in-class humanized monoclonal antibody (mAb) that targets the CC chemokine receptor 4 (CCR4), a protein that is persistently expressed on SS and MF cancer cells. a protein. Once Whither binds to CCR4, it activates more immune cells in the body’s immune system, which in turn destroys cancer cells.
Cutaneous T-cell lymphoma (CTCL) is a rare type of non-Hodgkin lymphoma. SS and MF are the two most common subtypes of CTCL, which can involve the patient’s skin, blood, lymph nodes, and internal organs. CTCL is rare, with approximately 24 cases per 100,000 people. The annual incidence of MF in Europe is about 1/110,000 to 1/350,000, while the annual incidence of SS is 1/10 million. Combined, these two subtypes account for about 65% of all CTCL cases. Patients generally suffer from poor quality of life, high rates of misdiagnosis, and a lack of targeted therapy in late stages, often with skin lesions, itching, pain, and unpredictable skin symptoms that may lead to further complications that affect their life expectancy. Because CTCL is similar to common skin conditions such as eczema and psoriasis, patients take an average of 2-7 years to be diagnosed. Patients with advanced disease had a significantly worse prognosis, with about half (52%) surviving only 5 years.
Professor Shi Yuankai of Cancer Hospital, Chinese Academy of Medical Sciences said: “Sézary syndrome and mycosis fungoides have brought a heavy burden to the quality of life of patients. The approval of moglizumab will bring a new opportunity for such patients in China. A treatment option with a novel mechanism of action. Moglizumab improved symptoms and quality of life in patients, and the patient’s skin lesions and hematological indicators showed a significant and durable effect on moglizumab treatment, with a median progression free Survival was significantly prolonged.
[Reporter] Yan Huifang
【Author】 Yan Huifang
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