On April 26 2011 Kyowa Hakko Kirin reported that it has submitted a new drug application (NDA) to the Ministry of Health, Labour and Welfare for KW-0761 under development for the treatment of adult T-cell leukemia-lymphoma (ATL) (Press release Kyowa Hakko Kirin, APR 26, 2011, View Source [SID:1234500291]).
KW-0761 is a humanized monoclonal antibody produced by applying POTELLIGENT, a technology to produce antibodies with enhanced ADCC activity which was developed exclusively by Kyowa Hakko Kirin. This product is the first antibody for which Kyowa Hakko Kirin has submitted a NDA, and is also the world’s first POTELLIGENT antibody to be submitted for marketing approval. KW-0761 binds to CCR4 that is expressed on the surface of ATL cells. Clinical studies of KW-0761 in patients with relapsed CCR4-positive ATL in Japan met their primary endpoint, which allowed Kyowa Hakko Kirin to submit an NDA. KW-0761 was also granted an orphan drug designation for the treatment of CCR4-positive ATL by the Ministry of Health, Labour and Welfare.

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