Mogamulizumab-kpkc (Poteligeo, Kyowa Kirin) injection is indicated to treat adult patients with 2 types of non-Hodgkin lymphoma: relapsed or refractory mycosis fungoides or SÃ©zary syndrome.
Officials with the FDA have approved a new treatment for 2 rare types of non-Hodgkin lymphoma of the skin, relapsed or refractory mycosis fungoides (MF) and Sézary syndrome (SS), after at least 1 prior systemic therapy, according to a press release.
Mogamulizumab-kpkc (Poteligeo, Kyowa Kirin) injection received approval for intravenous use in adult patients, providing a new therapeutic option for patients with MF and the first approval of a drug specifically for SS, according to the release.
MF and SS are both types of non-Hodgkin lymphoma that affect the skin. MF accounts for approximately half of lymphomas arising from the skin and SS is a rare form of skin lymphoma that affects the blood and lymph nodes.
The approval was based on the results of a clinical trial of 372 patients with relapsed MF or SS that evaluated treatment with mogamulizumab-kpkc compared with vorinostat chemotherapy. Based on the data, patients who received mogamulizumab-kpkc experienced a longer median progression-free survival (7.6 months) compared with those taking vorinostat (3.1 months).
The most common adverse effects associated with the treatment included rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection.
“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 press release.
Mogamulizumab-kpkc, a monoclonal antibody, binds to a protein called CC chemokine receptor type 4, or CCR4, found on some cancer cells.
The agency previously granted the application Priority Review, Breakthrough Therapy designation, and Orphan Drug designation.
FDA approves treatment for two rare types of non-Hodgkin lymphoma [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM616176.htm?utm_campaign=08082018_PR_FDA%20approves%20new%20drug%20for%20two%20rare%20types%20of%20non-Hodgkin%20lymphoma&utm_medium=email&utm_source=Eloqua. Accessed August 8, 2018.