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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:  https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761051s000lbl.pdf