FDA grants Breakthrough Therapy designation for mogamulizumab

The US Food and Drug Administration has granted Breakthrough Therapy designation status to the investigational product mogamulizumab, which is being developed for the treatment of mycosis fungoides (MF) and Sézary syndrome (SS) in adult patients who have received at least one prior systemic therapy, by Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151).

MF and SS are the two most common subtypes of CTCL, a rare type of non-Hodgkin's lymphoma, which is characterized by localization of malignant T lymphocytes to the skin, and depending on the stage, the disease may involve skin, blood, lymph nodes, and viscera.

"We are excited to hear mogamulizumab received such a valuable designation," said Mitsuo Satoh, executive officer, vice president, head of R&D Division at Kyowa Hakko Kirin. "We will keep on making effort to provide this antibody to patients with these conditions worldwide."