The US Food and Drug Administration (FDA) approved mogamulizumab-kpkc (Poteligeo) intravenous (IV) injection for the treatment of adult patients with relapsed/refractory (R/R) mycosis fungoides (MF) or Sézary syndrome (SS) previously treated with at least 1 systemic therapy, according to a news release.1
Approval for mogamulizumab — a humanized monoclonal antibody that targets CC chemokine receptor type 4 (CCR4) — provides a new treatment option for patients with MF and marks the first FDA-approved therapy for SS. MF and SS are difficult-to-treat subtypes of cutaneous T-cell lymphoma (CTCL), a class of non-Hodgkin lymphoma that affects the skin.
The FDA based its approval on data of the MAVORIC phase 3 (ClinicalTrials.gov Identifier: NCT01728805), in which researchers randomly assigned 372 patients with MF or SS to IV mogamulizumab 1 mg/kg weekly for 4 weeks then every other week thereafter or oral vorinostat 400 mg daily.
Results showed that patients in the mogamulizumab arm had a progression-free survival (PFS) of 7.6 months (95% CI, 5.6-10.2) vs 3.1 months (95% CI, 2.8-4.0) in the vorinostat arm (hazard ratio [HR], 0.53; 95% CI, 0.41-0.69; P <.001).2
The overall response rate was 28% and 5% for the mogamulizumab and vorinostat arms, respectively (P <.001).
The most frequently reported adverse events associated with mogamulizumab were diarrhea, fatigue, infusion-related reactions, musculoskeletal pain, rash, and upper respiratory tract infection. Serious treatment warnings included the risk of autoimmune problems, dermatologic toxicity, infusion reactions, and stem cell transplant complications.
1. FDA approves treatment for two rare types of non-Hodgkin lymphoma [news release]. Silver Springs, MD: US Food and Drug Administration; August 8, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM616176.htm?utm_campaign=08082018_PR_FDA%20approves%20new%20drug%20for%20two%20rare%20types%20of%20non-Hodgkin%20lymphoma&utm_medium=email&utm_source=Eloqua. Accessed August 8, 2018.
2. Kyowa Kirin announces FDA approval of Poteligeo® (mogamulizumab-kpkc) for the treatment of mycosis fungoides and Sézary syndrome [news release]. Tokyo, Japan: Kyowa Hakko Kirin Co, Ltd; August 8, 2018. https://www.prnewswire.com/news-releases/kyowa-kirin-announces-fda-approval-of-poteligeo-mogamulizumab-kpkc-for-the-treatment-of-mycosis-fungoides-and-sezary-syndrome-300694118.html. Accessed August 8, 2018.