Poteligeo mogamulizumab regulatory update

Kyowa said Japan's Ministry of Health, Labor and Welfare (MHLW) approved a label expansion for Poteligeo mogamulizumab to treat relapsed or refractory, CC chemokine receptor 4 (CCR4; CD194)-positive peripheral T cell lymphoma (PTCL) and cutaneous T cell lymphoma (CTCL). Last month, Kyowa withdrew part of an sNDA seeking to expand Poteligeo's label to include treatment of previously untreated CCR4-positive adult T cell leukemia-lymphoma (ATL) after the agency determined that additional information was needed to support approval in the indication (see BioCentury, Feb. 24). ...