The FDA Calls Kyowa Hakko's Lymphoma Drug a Breakthrough

Published: Aug 25, 2017

The FDA Calls Kyowa Hakko Kirin's Lymphoma Drug a Breakthrough
August 25, 2017
By Alex Keown, BioSpace.com Breaking News Staff

TOKYO – The U.S. Food and Drug Administration granted its Breakthrough Therapy Designation to a drug that has been available to lymphoma patients in Japan for several years.

The FDA granted the designation to Tokyo-based Kyowa Hakko Kirin Co., Ltd. for its investigational product, mogamulizumab which is being developed as a second-line treatment of two types of non-Hodgkin’s lymphoma. Mogamulizumab, a humanized monoclonal antibody (mAb), is being developed for 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 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. Mogamulizumab targets CC chemokine receptor 4 (CCR4), which is frequently expressed on leukemic cells of certain hematologic malignancies including CTCL.

Mitsuo Satoh, head of Kyowa Hakko Kirin’s research and development, said the company was excited about the designation and aimed to bring the treatment to market in the U.S. and worldwide in order to provide therapy to patients.

The FDA’s designation was based on data from the company’s MAVORIC (Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL) study. Kyowa Hakko Kirin billed the 372 patient study as the largest randomized trial in CTCL. MAVORIC is a Phase III study testing mogamulizumab against vorinostat (Merck’s Zolinza) in patients with MF and SS who have failed at least one prior systemic treatment.

The company said it is working with investigators on the future presentation and publication of clinical trial results.

Mogamulizumab has been in development for some time and has been used in combination studies with other companies, including Bristol-Myers Squibb. The U.S. company paired mogamulizumab with its PD-1 immune checkpoint inhibitor Opdivo as a potential treatment option for patients with advanced or metastatic solid tumors. In 2014, Pfizer also sought to pair mogamulizumab with utomilumab to treat solid tumors.

In addition to seeking approval in the United States, Kyowa Hakko Kirin said it has also initiated discussions with other regulatory authorities concerning plans for marketing authorization applications for mogamulizumab in CTCL in other countries.

The FDA’s designation came one day after Kyowa Hakko Kirin and its U.S. partner Ultragenyx filed for approval of burosumab to treat X-Linked Hypophosphatemia (XLH) in the US. Burosumab has previously received Breakthrough Therapy Designation from the FDA for the treatment of XLH in pediatric patients one year of age and older.

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