WEDNESDAY, Aug. 8, 2018 -- Poteligeo (mogamulizumab) injection has been approved by the U.S. Food and Drug Administration to treat adults with two types of non-Hodgkin lymphoma.
The drug was approved to treat relapsed or refractory mycosis fungoides (MF) and Sézary syndrome (SS) after the patient has had at least one prior therapy delivered through the bloodstream.
"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," Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence, said in an agency news release.
Non-Hodgkin lymphoma is a cancer that starts in immune-boosting white blood cells called lymphocytes. When these cells become cancerous, the skin develops itchy rashes and lesions that may spread beyond the original site.
Poteligeo's approval was based on clinical studies involving 372 people with relapsed MF or SS, who were given either Poteligeo or a chemotherapy drug called vorinostat. Progression-free survival averaged 7.6 months for those who took Poteligeo, versus 3.1 months among those who took vorinostat, the agency said Wednesday.
Poteligeo's most common side effects included rash, injection-site reactions, fatigue, diarrhea, bone/muscle pain and respiratory tract infections. More serious side effects could include toxic skin reactions, autoimmune reactions and infections, the FDA said.
The drug is produced by the Japanese drugmaker Kyowa Kirin Inc.
The FDA has more about this approval.
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