Officials with the FDA have approved a new treatment for 2 rare types of non-Hodgkin lymphoma of the skin.
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).
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