Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151) has received approval for additional indication for relapsed or refractory CCR4-positive peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) for Poteligeo (mogamulizumab injection) from Japan's Ministry of Health, Labor and Welfare (MHLW).
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.
Poteligeo was launched in Japan in May 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.
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