Kyowa Hakko Kirin Co. Ltd.'s medicine Poteligeo has been approved by the U.S. Food and Drug Administration to treat two rare types of non-Hodgkin lymphoma.
The Tokyo-based company's drug, also known as mogamulizumab, treats adult patients with mycosis fungoides and Sézary syndrome whose cancer has returned, or is resistant or nonresponsive to at least one prior therapy.
Non-Hodgkin lymphoma is a cancer that starts in white blood cells called lymphocytes, which are part of the body's immune system. Mycosis fungoides and Sézary syndrome are types of non-Hodgkin lymphoma in which lymphocytes become cancerous and affect the skin. About half of all lymphomas of the skin are of the mycosis fungoides type, which causes rashes and skin lesion and eventually spread cancer to other parts of the body. Sézary syndrome, however, is a much rarer form of skin lymphoma affecting the blood and lymph nodes.
The approval was based on a phase 3 trial consisting of 372 patients who received either Poteligeo or Merck & Co. Inc.'s Zolinza, also known as vorinostat, the FDA said in an Aug. 8 statement. The trial showed that patients who received Poteligeo lived longer without cancer progression compared to patients taking Zolinza.
The FDA granted Poteligeo breakthrough therapy and orphan drug designations, which provide incentives to develop drugs for serious conditions and rare diseases.