The FDA approved mogamulizumab-kpkc for adults with relapsed/refractory mycosis fungoides (MF) or Sézary syndrome (SS)—two rare forms of non-Hodgkin lymphoma—who have received at least one prior systemic therapy. This injectable monoclonal antibody is the first FDA approval for SS.
The decision was based on results of a clinical trial that included 372 patients with relapsed MF or SS who received mogamulizumab-kpkc or vorinostat. Median progression-free survival was longer for those receiving mogamulizumab-kpkc compared with vorinostat (7.6 vs. 3.1 months).
#BREAKING: The @US_FDA has approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use for the treatment of adult patients with relapsed or refractory #mycosis #fungoides or #Sezary syndrome after at least 1 prior systemic therapy.
— Rare Disease Report (@RareDR) August 8, 2018
The most common adverse events associated with mogamulizumab-kpkc include rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection.
Serious AEs associated with mogamulizumab-kpkc include dermatologic toxicity, infusion reactions, infections, autoimmune problems, and complications of allogeneic hematopoietic cell transplantation following use of mogamulizumab-kpkc.