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FDA Approves Intravenous Injection for Rare Forms of Non-Hodgkin Lymphoma
The US Food and Drug Administration (FDA) has granted approval to an intravenous injection for the treatment of adults with 2 rare types of non-Hodgkin lymphoma.
Mogamulizumab-kpkc (Poteligeo; Kyowa Kirin) is now authorized for use as an intravenous injection in patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) who were previously treated with 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. We are committed to continuing to expedite the development and review of this type of targeted therapy that offers meaningful treatments for patients,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence in a press statement released by the agency (August 8, 2018).
This approval is based on results from a clinical trial of 372 patients with relapsed MF or SS who received treatment with mogamulizumab-kpkc or chemotherapy. Results showed a significantly longer median progression-free survival (PFS) for patients in the mogamulizumab-kpkc arm versus patients in the chemotherapy arm (7.6 vs 3.1 months, respectively).
The most common side effects associated with use of mogamulizumab-kpkc include rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection.—Janelle Bradley
