FDA Grants Mogamulizumab Priority Review for CTCL

November 28, 2017 – The FDA has granted a priority review to a biologics license application (BLA) for mogamulizumab for the treatment of patients with cutaneous T-cell lymphoma (CTCL) who have received at least 1 prior systemic therapy, according to Kyowa Hakko Kirin, the manufacturer of the anti-CCR4 monoclonal antibody. The BLA is based on findings from the phase III MAVORIC study, results of which are scheduled to be presented in December at the 2017 … (leggi tutto)