The Food and Drug Administration (FDA) has approved Poteligeo (mogamulizumab-kpkc; Kyowa Kirin) injection for the treatment of adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after ≥1 prior systemic therapy. Poteligeo is the first approved treatment for SS. 

MF and SS are rare types of non-Hodgkin lymphoma where lymphocytes become malignant and affect the skin. They are also the 2 most common subtypes of cutaneous T-cell lymphoma (CTCL) with MF accounting for 50 to 70% of cases.

Poteligeo, a defucosylated, humanized IgG1 kappa monoclonal antibody, binds to CC chemokine receptor type 4 (CCR4) that is involved in the trafficking of lymphocytes to organs. In vitro studies showed that this binding targets a cell for antibody-dependent cellular cytotoxicity resulting in depletion of the target cells. The propriety POTELLIGENT technology reduces the amount of fucose in the sugar chain structure thus boosting the antibody dependent cellular cytotoxicity. 

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The FDA approval was supported by data from MAVORIC, a phase 3, randomized, open-label, multicenter trial (N=372) of patients with relapsed MF or SS who received Poteligeo or vorinostat (Zolinza; Merck). 

The data showed progression-free survival was longer for patients in the Poteligeo group vs the vorinostat group (7.6 months vs 3.1 months, hazard ratio [HR] 0.53, 95% CI, 0.41, 0.69; P<.001). The confirmed overall response rate for Poteligeo was 28% vs 5% for vorinostat (P<.001). 

Poteligeo was previously granted Priority Review, Breakthrough Therapy, and Orphan Drug Designation. It will be available as a 20mg/5mL (4mg/mL) strength solution for intravenous (IV) injection in single-dose vials. Poteligeo is anticipated to launch in the fourth quarter of 2018. 

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