Posted by Michael Wonder on 27 Aug 2017
US Food and Drug Administration grants breakthrough therapy designation for mogamulizumab for the treatment of mycosis fungoides and Sézary syndrome
25 August 2017 - Kyowa Hakko Kirin today announced that U.S. FDA has granted breakthrough therapy designation status to their investigational product, mogamulizumab which is being developed for the treatment of mycosis fungoides and Sézary syndrome, in adult patients who have received at least one prior systemic therapy. Mycosis fungoides and Sézary syndrome are the most common subtypes of cutaneous T-cell lymphoma.
Breakthrough therapy designation was granted based on the data from the MAVORIC (Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL) study. This global study is the largest randomised trial in CTCL. Kyowa Hakko Kirin is working with investigators on the future presentation and publication of clinical trial results.
