Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151 President and CEO: Nobuo Hanai; announces the submission of a supplemental application to remove the requirement for pre-treatment diagnostic testing and change the dosage and administration in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) * for mogamulizumab* (code name: KW-0761; brand name: POTELIGEO®) to the Ministry of Health, Labor and Welfare in Japan.
The application is supported by data from the MAVORIC (Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL)* study, the largest global randomized clinical trial of systemic therapy in CTCL. The MAVORIC study did not require identification of CCR4 positive cells in patients before enrollment into the study. The application is intended to remove the requirement for diagnostic testing for CCR4 expression before administration of the drug for CTCL, which is required in the current approval of CTCL, and to change the dosage schedule for CTCL.
“We are happy to file the application of mogamulizumab in CTCL in Japan,” said Mitsuo Satoh, Ph.D., Executive Officer, Vice President Head of R&D Division of Kyowa Hakko Kirin. “We believe results of the MAVORIC study indicates mogamulizumab can help to treat CTCL in an expanded patient population.”
Mogamulizumab currently has no approved indications outside of Japan, and has been recently submitted Marketing Authorization Application in EU and Biologics License Application in the US. The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.
About CTCL (Cutaneous T-cell Lymphoma) CTCL is a rare type of non-Hodgkin’s T-cell lymphoma. The two most common types of CTCL are mycosis fungoides (MF) and Sézary syndrome (SS), and depending on the stage, the disease may involve skin, blood, lymph nodes, and viscera. In advanced stage CTCL is associated with significant morbidity and mortality.