On August 8, 2018, the FDA approved mogamulizumab-kpkc (Poteligeo; Kyowa Kirin) injection, a monoclonal antibody, for use after at least 1 other systemic therapy, for the treatment of adults with relapsed or refractory mycosis fungoides or Sézary syndrome—2 uncommon types of non-Hodgkin lymphoma that have few or no FDA-approved treatment options. The FDA used its priority review for this approval and assigned mogamulizumab-kpkc breakthrough therapy and orphan drug designations. This is the first drug approved by the FDA specifically for the treatment of patients with Sézary syndrome.
“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 the FDA’s Oncology Center of Excellence. “We are committed to continuing to expedite the development and review of this type of targeted therapy that offers meaningful treatments for patients,” he added.
The FDA approved this new systemic targeted therapy based on results of a clinical trial that included 372 patients with relapsed mycosis fungoides or Sézary syndrome. Patients were randomized to receive mogamulizumab-kpkc or chemotherapy with vorinostat (Zolinza; approved for advanced cutaneous T-cell lymphoma). The median progression-free survival (PFS) was 7.6 months with mogamulizumab-kpkc versus 3.1 months with vorinostat, a significant improvement in PFS.
Like other monoclonal antibodies, treatment with mogamulizumab-kpkc carries the risk for serious complications, such as dermatologic toxicity, infusion reactions, infections, autoimmune problems, and allogeneic stem-cell problems, including severe and refractory graft-versus-host disease. Overall, 36% of patients had serious adverse events, which included serious infections in 16% of patients. The most common (≥20%) adverse events reported with mogamulizumab-kpkc were rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection.