Mogamulizumab to treat 2 non-Hodgkin’s lymphomasSeptember 14, 2018
Mogamulizumab-kpkc (Poteligeo) injection for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) has been approved for sale in the US.
This approval provides a new treatment option for patients with MF and is the first FDA approval of a drug specifically for SS.
Developed by Kyowa Kirin, Inc., mogamulizumab-kpkc is a monoclonal antibody that binds to a protein (called CC chemokine receptor type 4 or CCR4) found on some cancer cells.
The approval was based on a clinical trial of 372 patients with relapsed MF or SS who received either mogamulizumab-kpkc or a type of chemotherapy called vorinostat. Progression-free survival was longer for patients taking Poteligeo (median 7.6 months) compared to patients taking vorinostat.
The FDA granted mogamulizumab-kpkc application Priority Review and Breakthrough Therapy designation. It also received Orphan Drug designation.