- On August 8, the FDA approved mogamulizumab (Poteligeo) injection for intravenous use in the treatment of adults with relapsed/refractory mycosis fungoides (R/R MF) or Sézary syndrome (SS) following 1 or more systemic therapies.
Why this matters
- Sézary syndrome is a rare form of cutaneous non-Hodgkin’s lymphoma affecting the blood and lymph nodes.
- This is the first ever drug to receive FDA approval specifically for the treatment of Sézary syndrome.
- The approval was based on results of a clinical trial to investigate mogamulizumab vs vorinostat in 372 patients with relapsed MF or SS.
- Funding: Kyowa Kirin, Inc.
- 7.6 months median PFS with mogamulizumab vs 3.1 months with vorinostat.
- In patients receiving mogamulizumab, the most common adverse events (AEs) included rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection.
- Serious warnings for mogamulizumab treatment include risk of dermatologic toxicity, infusion reactions, infections, autoimmune problems, and complications of allogeneic hematopoietic stem cell transplantation.
- Approved under breakthrough therapy designation, entailing abbreviated or condensed review and potentially contingent upon future trial outcomes.