medwireNews: A monoclonal antibody agent targeting the C-C chemokine receptor 4 may now be used for US patients with relapsed or refractory Sézary syndrome or mycosis fungoides.
The FDA approval follows findings from a clinical trial of 327 patients with these rare non-Hodgkin lymphoma (NHL) forms who had received at least one prior treatment. Compared with use of vorinostat, patients using mogamulizumab-kpkc had significantly longer progression-free survival.
The agent carries serious warnings for skin toxicity, infection, autoimmune reactions and complications related to later use of allogeneic stem cell transplantation.
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