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FDA grants breakthrough therapy designation to mogamulizumab for mycosis fungoides, Sézary syndrome
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The FDA granted breakthrough therapy designation to mogamulizumab for the treatment of mycosis fungoides and Sézary syndrome, according to the agent’s manufacturer.
Mogamulizumab (Poteligeo, Kyowa Hakko Kirin Co. Ltd.) is a humanized monoclonal antibody directed against CC chemokine receptor 4, often expressed on leukemic cells of cutaneous T-cell lymphoma and other hematologic malignancies.
The investigational agent is intended to treat adults with mycosis fungoides and Sézary syndrome — the most common cutaneous T-cell lymphoma subtypes — who received at least one prior systemic therapy.
The FDA based the breakthrough therapy designation on results from the randomized phase 3 MAVORIC study, which compared mogamulizumab with vorinostat (Zolinza, Merck) in 372 patients with mycosis fungoides and Sézary syndrome who failed at least one prior systemic treatment. Trial results will be presented and published at a later date, according to a Kyowa Hakko Kirin Co. Ltd.-issued press release.
“We are excited to hear mogamulizumab received such a valuable designation,” Mitsuo Satoh, PhD, executive officer, vice president, and head of the research and development division of Kyowa Hakko Kirin, said in the release. “We will keep on making effort to provide this antibody to patients with these conditions worldwide.”