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