On August 8, the U.S. Food and Drug Administration approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use in the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. This approval provides a new treatment option for patients with mycosis fungoides and is the first FDA approval of a drug specifically for Sézary syndrome.
Richard Pazdur, MD
“Mycosis fungoides and Sézary syndrome are rare, hard-to-treat types of non-Hodgkin lymphoma, and this approval fills an unmet medical need for these patients,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence and Acting Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
Mycosis fungoides and Sézary syndrome are types of non-Hodgkin lymphoma in which lymphocytes become cancerous and affect the skin. Mycosis fungoides accounts for about half of all lymphomas arising from the skin. Sézary syndrome is a rare form of skin lymphoma that affects the blood and lymph nodes.
Study 0761-010
The approval of mogamulizumab-kpkc, a CC chemokine receptor type 4–directed monoclonal antibody, was based on a randomized, open-label, multicenter trial (Study 0761-010) in patients with active mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. Patients enrolled had received a median of three prior therapies. The trial randomized 372 patients (44% with Sézary syndrome) to receive either mogamulizumab-kpkc or vorinostat (Zolinza).
Progression-free survival was statistically significantly longer in the mogamulizumab-kpkc arm. The estimated median progression-free survival was 7.6 months (95% confidence interval [CI] = 5.6–10.2 months) for those treated with mogamulizumab-kpkc compared with 3.1 months (95% CI = 2.8–4.0 months) in the vorinostat arm (hazard ratio = 0.53, 95% CI = 0.41–0.69). The confirmed overall response rates were 28% and 5%, respectively (P < .001).
The prescribing information includes warnings for dermatologic toxicity, infusion reactions, infections, autoimmune complications, and complications of allogeneic hematopoietic stem cell transplantation. The recommended mogamulizumab-kpkc dose is 1 mg/kg administered as an intravenous infusion over at least 60 minutes. Mogamulizumab-kpkc is administered on days 1, 8, 15, and 22 of the first 28-day cycle, then on days 1 and 15 of subsequent 28-day cycles until disease progression or unacceptable toxicity. ■
