The FDA has approved a new drug to treat 2 rare types of non-Hodgkin lymphoma based on phase 3 clinical trial results that found mogamulizumab-kpkc improved progression-free survival and had a higher overall response rate compared with the chemotherapy vorinostat.
Patients with 2 rare types of non-Hodgkin lymphoma will now have a new treatment option. Mogamulizumab-kpkc (sold as Poteligeo by Kyowa Hakko Kirin) has been approved by the FDA to treat adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least 1 prior systemic therapy.
This is the first FDA-approved drug to specifically treat SS, which is a rare form of skin lymphoma that affects the blood and lymph nodes. MF accounts for about half of all lymphomas arising from the skin and can spread to other parts of the body.
“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 in the FDA’s Center for Drug Evaluation and Research, said in a statement.
Mogamulizumab-kpkc is a monoclonal antibody that binds to CC chemokine receptor 4, which is frequently expressed on leukemic cells of certain blood cancers.
The FDA approved the drug based on MAVORIC, a phase 3 open-label, multicenter, randomized trial of 372 patients with relapsed MF or SS who received either mogamulizumab-kpkc or the chemotherapy agent vorinostat. The study was conducted in the United States, Europe, Japan, and Australia.
The trial found that patients taking mogamulizumab-kpkc had median a progression-free survival of 7.6 months compared with median 3.1 months for patients on vorinostat. In addition, the overall response rate for mogamulizumab-kpkc was 28% compared with 5% for vorinostat.
"Mycosis fungoides and Sézary syndrome can be disfiguring, and debilitating," Jeffrey S. Humphrey, MD, president of Kyowa Kirin Pharmaceutical Development, Inc, said in a statement. "We look forward to the publication of MAVORIC's primary results and to ongoing scientific exchange within the medical and academic communities."
The most common adverse reactions were rash (35%), infusion reaction (33%), fatigue (31%), diarrhea (28%), upper respiratory tract infection (22%), musculoskeletal pain (22%), and skin infection (19%). Serious warnings of treatment with mogamulizumab-kpkc include the risk of dermatologic toxicity, infusion reactions, infections, autoimmune problems, and complications of stem cell transplantation after treatment.