The U.S. Food and Drug Administration granted priority review to Kyowa Hakko Kirin Co. Ltd.'s biologics license application for mogamulizumab to treat cutaneous T-cell lymphoma, or CTCL, in patients who have received at least one prior systemic therapy.
The FDA should make a decision by around June 4, 2018.
Mogamulizumab was first approved in Japan in 2012 for different blood-related malignancies and in 2014 for use in CTCL.
The FDA granted breakthrough therapy designation to the treatment for mycosis fungoides and Sézary syndrome, sub-types of CTCL, in patients who have received at least one prior systemic therapy.
Kyowa Hakko Kirin is also seeking the European Medicines Agency's approval of mogamulizumab in CTCL patients.
CTCL is a class of non-Hodgkin lymphoma, a cancer of the immune system.
