On March 17, 2014 Kyowa Hakko Kirin reported that it has received approval for additional indication for relapsed or refractory CCR4-positive peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) of Mogamulizumab (brand name: POTELIGEO Injection) from Japan’s Ministry of Health, Labour and Welfare (MHLW) (Press release Kyowa Hakko Kirin, MAR 17, 2014, View Source [SID:1234500287]).
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Mogamulizumab is a novel, humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4), which is over-expressed on various malignant T cells, including PTCL and CTCL cells. Engineered by Kyowa Hakko Kirin’s unique POTELLIGENT Technology, the antibody is designed to kill its target cells through potent antibody-dependent cellular cytotoxicity (ADCC). Mogamulizumab was also granted orphan drug designations for the treatment of PTCL and CTCL in March 2013 by the MHLW.
Mogamulizumab was launched in Japan with the brand name POTELIGIO Injection 20 mg on May 29, 2012 for the treatment of patients with relapsed or refractory CCR4-positive ATL and is being investigated world-wide in a number of clinical studies for other potential indications.