FDA Grants Breakthrough Therapy Designation for Mogamulizumab

Kyowa Hakko Kirin announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to their 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. Mycosis Fungoides and Sézary Syndrome are the most common subtypes of cutaneous T-cell lymphoma (CTCL).

"We are excited to hear mogamulizumab received such a valuable designation," said Mitsuo Satoh, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Hakko Kirin. "We will keep on making effort to provide this antibody to patients with these conditions worldwide."

Breakthrough Therapy Designation was granted based on the data from the MAVORIC (Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL) study. This global study is the largest randomized trial in CTCL. Kyowa Hakko Kirin is working with investigators on the future presentation and publication of clinical trial results.

According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and regulatory review of therapies for serious or life-threatening conditions and whose preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on one or more clinically significant endpoints over existing therapies. Under the designation, the FDA provides intensive guidance, organizational commitment involving senior managers, and eligibility for rolling and priority review of the marketing application; this process is intended to ensure that safe and effective therapies for serious conditions are approved and available to patients faster than through conventional approval pathways.

Kyowa Hakko Kirin has also initiated discussions with other regulatory authorities concerning plans for marketing authorization applications for mogamulizumab in CTCL in other countries.