The FDA today approved an intravenous drug Poteligeo (mogamulizumab-kpkc) for adults with recurrent or refractory non-hodgkin lymphoma who have received one or more systemic therapies. They were mycosis fungoides (MF) and cezali syndrome (SS). The approval of Poteligeo provides a new treatment for mycosis fungoides and is the first drug for sezari syndrome.
"Mycosis fungoides and serzali syndrome are rare and refractory non-hodgkin's lymphomas, and this approval gives these patients new treatment options, and we will continue to accelerate the development and review of such targeted therapies of great significance to these patients."
Non-hodgkin's lymphoma is a cancer of the lymphocytes that are part of the body's immune system. Mycosis fungoides and serzali syndrome are rare non-hodgkin's lymphomas involving the skin. Mycosis fungoides accounts for about half of cutaneous lymphoma, causing itchy rashes and skin lesions that can spread to other parts of the body. Sezary syndrome is more rare and affects blood and lymph nodes.
The approval of Poteligeo, a monoclonal antibody against CCR4 protein on cancer cells, was based on a clinical trial involving 372 patients with recurrent mycosis fungoides and serzali syndrome. The patients were divided into two groups and treated with Poteligeo or Vorinostat, a chemotherapy drug. Results showed that the median progression-free survival was 7.6 months in the Poteligeo group and 3.1 months in the Vorinostat group.
The most common side effects of Poteligeo treatment included skin rashes, infusion related adverse reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infections.
Poteligeo therapy may also lead to increased risks of skin toxicity, infections, autoimmune diseases, and complications of allogeneic stem cell transplantation following drug therapy.