Breakthrough Therapy Designation status has been granted to Kyowa Hakko Kirin Co, Ltd. for mogamulizumab to treat 2 subtytes of cutaneous T-cell lymphoma (CTCL) – mycosis fungoisis (MF) and Sézary syndrome (SS).
The investigational product is currently in development to treat adult patients with MF or SS who have had at least 1 prior systemic therapy.
The designation is intended to expedite the development and regulatory review of therapies for serious or life-threatening conditions that show promising clinical evidence.
MF, also known as Alibert-Bazin Syndrome, and SS are subtypes of cutaneous T-cell carcinoma (CTCL), a rare form of non-Hodgkin’s lymphoma. MF generally affects the skin, but could progress internally over time. SS is more aggressive, and characterized by a widespread red rash that may cover most of the body. Common symptoms of both include itchiness and tumors.
Breakthrough Therapy Designation was granted based on data from the Phase 3 Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL (MAVORIC) study, the largest randomized trial in CTCL. In the study, mogamulizumab was compared to vorinostat in patients with MF and SS who had previously failed a minimum of 1 prior systemic treatment. Details of the data from this trial are currently not publically available, but the company did report
in April that top-line results showed a statistically significant improvement in progression-free survival in the mogamulizumab-treated group in comparison to thevorinostat-treated group.
Mogamulizumab is a humanized monoclonal antibody directed against the CC chemokine receptor 4 (CCR4), which is frequently expressed on leukemic cells of some hematologic malignancies including 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 in a press release
. “We will keep on making effort to provide this antibody to patients with these conditions worldwide.”
Discussions with other regulatory authorities have already been initiated in an effort to develop plans for marketing authorization applications for mogamulizumab in CTCL in other countries.
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