Poteligeo (mogamulizumab) is an injection for adult patients with relapsed or refractory mycosis fungoides (MF) or Sezary syndrome (SS)—two rare forms of non-Hodgkin lymphoma.
The conditions are classified as hard to treat, occurring when lymphocytes become cancerous and affect the skin.
Poteligeo is the first drug approved for the treatment of Sezary syndrome specifically, developed by Kyowa Kirin. It is a monoclonal antibody (mAb) that binds to the protein CC chemokine receptor type 4 (CCR4) found on some cancer cells.
Monoclonal antibodies are molecules produced in a laboratory that act as the body’s own antibodies and can help the immune system fight cancer cells as they bind to antigens on the surface of cancer cells.
An FDA representative told us, “Patients enrolled in the clinical trial had a median of three prior therapies, and PFS [progression-free survival] and overall response rate were significantly improved in the Poteligeo arm. This approval provides patients with an additional treatment option.”
The clinical trial contained 372 participants, all with refractory or relapsed MF or SS, who were given either Poteligeo or vorinostat (a type of chemotherapy).
Participants given Poteligeo showed a higher PFS rate than those given vorinostat: patients receiving Poteligeo showed a median of 7.6 months progression-free survival rate, and those on vorinostat showed a median rate of 3.1 months.
A representative from the FDA said, that for lymphoma drug development, PFS is the most common endpoint used for regular approval.
Kyowa Kirin was recently granted FDA approval with a priority review and breakthrough therapy designation as well as an Orphan Drug designation for Poteligeo.