The Lymphoma Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy

Mogamulizumab-kpkc approved by the FDA for mycosis fungoides or Sezary syndrome

Aug 9, 2018

On 8 August 2018, the US Food and Drug Administrationapproved the use of mogamulizumab-kpkc (POTELIGEO) for adult patients with relapsed or refractory (R/R) mycosis fungoides (MF) or Sezary syndrome (SS) after at least one prior line of therapy. 

Mogamulizumab-kpkc is a CC chemokine receptor type 4 directed monoclonal antibody used to treat MF or SS, which is a type of cutaneous T-cell lymphoma (CTCL). The approval follows data from a randomized, multi-center, phase III trial ( NCT01728805) that compared patients with R/R MF or SS treated with either mogamulizumab-kpkc or vorinostat. Progression-free survival (PFS) was significantly superior in the mogamulizumab-kpkc treatment arm compared with vorinostat. The PFS for mogamulizumab-kpkc was 7.6 months (95% CI, 5.6, 10.2) and the PFS for vorinostat was 3.1 months (95% CI, 2.8, 4.0), (HR 0.53, 95% CI, 0.41, 0.69),  < 0.001. The overall response rate (ORR) for mogamulizumab-kpkc was 28% compared with 5% for vorinostat,  < 0.001.

Full prescribing information: