FDA approves treatment for two rare types of non-Hodgkin lymphoma

FDA has approved mogamulizumab-kpkc (Poteligeo—Kyowa Kirin) injection for I.V. use for the treatment of adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.

FDA has approved mogamulizumab-kpkc (Poteligeo—Kyowa Kirin) injection for I.V. use for the treatment of adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. "Mycosis fungoides and Sézary syndrome are rare, hard-to-treat types of non-Hodgkin lymphoma, and this approval fills an unmet medical need for these patients," said Richard Pazdur, MD, director of FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research. Approval of the monoclonal antibody that binds to a protein found on some cancer cells was based on a clinical trial of 372 patients with relapsed MF or SS who received either mogamulizumab-kpkc or a type of chemotherapy called vorinostat. For patients taking mogamulizumab-kpkc, the median progression-free survival was 7.6 months, compared with a median of 3.1 months for patients taking vorinostat. The most common adverse effects of treatment with mogamulizumab-kpkc included rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection. Serious warnings of treatment with the drug include the risk of dermatologic toxicity, infusion reactions, infections, autoimmune problems, and complications of stem cell transplantation that uses donor stem cells after treatment with the drug.