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FDA approves Poteligeo for mycosis fungoides, Sézary syndrome
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The FDA approved mogamulizumab-kpkc injection for the treatment of adults with relapsed or refractory mycosis fungoides and Sézary syndrome after at least one prior systemic therapy.
This approval marks the first drug indicated specifically for the treatment of Sézary syndrome.
Mogamulizumab-kpkc (Poteligeo, Kyowa Kirin) is a monoclonal antibody that binds to CCR4 proteins occurring on some cancer cells.
“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,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products, said in a press release. “We are committed to continuing to expedite the development and review of this type of targeted therapy that offers meaningful treatments for patients.”
The FDA based the approval of mogamulizumab-kpkc on a clinical trial that included 372 patients with relapsed mycosis fungoides or Sézary syndrome. Patients received mogamulizumab-kpkc or vorinostat (Zolinza, Merck).
Median PFS was 7.6 months among patients treated with mogamulizumab-kpkc compared with 3.1 months among those assigned vorinostat.
The most common side effects associated with mogamulizumab-kpkc included rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain and upper respiratory tract infection.
Serious warnings include the risk for dermatologic toxicity, infusion reactions, infections, autoimmune problems and complications of allogeneic stem cell transplantation after treatment.
The FDA granted this application orphan drug designation, priority review and breakthrough therapy designation.