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.
- 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.
- 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.
This article originally appeared on ONA