The U.S. Food and Drug Administration (FDA) 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-kpkc the first FDA-approved option for patients with SS. (Editor’s note: In late 2017, the FDA revised its policy for naming biologics: All newly approved biologics will receive a four-letter suffix after their nonproprietary name. This represents a shift from adding suffixes only to biosimilar versions of products to distinguish them from their reference products.)
The agency’s approval was based on results from a clinical trial of 372 patients with relapsed or refractory MF or SS. Patients received either mogamulizumabkpkc or the histone deacetylase inhibitor vorinostat. Median progression-free survival was longer for patients receiving mogamulizumab-kpkc (7.6 months) than for patients receiving vorinostat (3.1 months; ranges and p value not provided).
The most common treatment-related adverse events (AEs) 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 HCT complications.
The FDA approved mogamulizumab-kpkc through priority review, and the agent was approved with breakthrough therapy and orphan drug designations.
Source: FDA news release, August 8, 2018.