The US Food and Drug Administration (FDA) has granted approval to biotechnology company Kyowa Kirin’s Poteligeo (mogamulizumab-kpkc) injection to treat adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS).
This makes Poteligeo the first one of a drug indicated specifically for SS and provides patients with MF with a new treatment option.
FDA Oncology Center of Excellence director Richard Pazdur said: “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.
“We are committed to continuing to expedite the development and review of this type of targeted therapy that offers meaningful treatments for patients.”
The Non-Hodgkin lymphoma cancer begins in white blood cells called lymphocytes, which form part of the body’s immune system.
In the MF and SS types of non-Hodgkin lymphoma, lymphocytes become cancerous and affect the skin.
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MF, which accounts for about half of all lymphomas arising from the skin, causes itchy red rashes and skin lesions and can spread to other parts of the body, while SS is a rare form of skin lymphoma that affects the blood and lymph nodes.
Poteligeo is a monoclonal antibody that binds to a protein called CC chemokine receptor type 4 or CCR4 found on some cancer cells.
FDA approval was based on a clinical trial carried out in 372 patients with relapsed MF or SS who received either Poteligeo or a type of chemotherapy called vorinostat.
The FDA has previously granted Kyowa Kirin’s application priority review and breakthrough designation, as well as designating Poteligeo as an orphan drug since it is indicated for a rare disease.
Rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain and upper respiratory tract infection were the most common side effects of treatment with Poteligeo.