The U.S. Food and Drug Administration (FDA) has approved mogamulizumab-kpkc for intravenous use in patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) – two rare forms of non-Hodgkin lymphoma. The approval makes mogamulizumab the first FDA-approved option for patients with SS. The FDA previously granted this application priority review, breakthrough therapy designation, and orphan drug designation.
The agency’s decision to approve the drug was based on results from a clinical trial of 372 patients with relapsed or refractory MF or SS. Patients received either mogamulizumab or the histone deacetylase inhibitor vorinostat. Median progression-free survival was longer for patients receiving mogamulizumab (7.6 months) than for patients receiving vorinostat (3.1 months; ranges and p value not provided).
The most common treatment-related adverse events included rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection. Serious warnings include the risk of dermatologic toxicity, infusion reactions, infections, autoimmune problems, and hematopoietic cell transplantation complications.
Source: FDA news release, August 8, 2018.