Posted by Michael Wonder on 28 Nov 2017
Kyowa Hakko Kirin announces FDA acceptance for filing and priority review designation of mogamulizumab’s biologics license application
28 November 2017 - Kyowa Hakko Kirin today announces that the U.S. FDA has accepted for review the biologics license application for mogamulizumab to treat cutaneous T-cell lymphoma in patients who have received at least one prior systemic therapy, and has granted priority review status.
The application is supported by the data from the MAVORIC (Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL) study, the largest global randomised clinical trial of systemic therapy in CTCL.
The Prescription Drug User Fee Act action date for the application is 4 June 2018.
