FDA Approves Drug for Rare Non-Hodgkin Lymphoma Types

The Food and Drug Administration (FDA) approved Poteligeo (mogamulizumab-kpkc) injection to treat patients with relapsed or refractory mycosis fungoides or Sézary syndrome — two rare types of non-Hodgkin lymphoma that affect the skin – after at least one prior line of systemic therapy, according to the agency.

Poteligeo, which is a monoclonal antibody that works by binding to the CCR4 protein on cancer cells, is the first approved to treat Sézary syndrome.

The approval was based on a clinical trial that included more than 370 patients with relapsed mycosis fungoides or Sézary syndrome who were given either Poteligeo or chemotherapy using vorinostat. Average progression-free survival (PFS) was more than twice as long in the Poteligeo arm compared with those who received chemotherapy (7.6 months vs. 3.1 months, respectively).

“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, M.D., 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, said in a statement.

The most common side effects associated with Poteligeo included rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain and upper respiratory tract infection. Serious side effects included dermatologic toxicity, infusion reactions, infections, autoimmune problems and complications with allogenic stem cell transplantation.

“We are committed to continuing to expedite the development and review of this type of targeted therapy that offers meaningful treatments for patients,” Pazdur added.