BRIEF—EMA validates MAA for T-cell lymphoma drug

Japan’s Kyowa Hakko Kirin has announced that its marketing authorization application (MAA) for mogamulizumab, for the treatment of cutaneous T-cell lymphoma (CTCL) in adults who have received at least one prior systemic therapy, has been validated by the European Medicines Agency (EMA) and is now under review.

Mogamulizumab was first approved in Japan 2012 for other hematological malignancies and in 2014 for use in CTCL.

Kyowa Hakko Kirin has also initiated discussions with regulatory authorities concerning plans for marketing authorization applications for mogamulizumab in CTCL in other countries.