Change to Supplemental Application Seeking Approval of Additional Indication for Mogamulizumab

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Tokyo, Japan, February 10, 2014 - Kyowa Hakko Kirin Co, Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") today announced a change to its supplemental new drug application for approval of Mogamulizumab (brand name: "POTELIGIO® Injection 20 mg") whereby it has temporarily withdrawn the part of its application for approval of additional indication for untreated CC chemokine receptor 4 (CCR4) positive adult T-cell leukemia-lymphoma (ATL).

Mogamulizumab was launched in Japan with the brand name "POTELIGIO® Injection 20 mg" on May 29, 2012 for the treatment of patients with relapsed or refractory CCR4-positive ATL.

On July 19, 2013, Kyowa Hakko Kirin filed a supplemental new drug application seeking approval for additional indication of Mogamulizumab for untreated CCR4-positive ATL, relapsed or refractory CCR4-positive peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL). However, through consultation with the regulatory agency, it was determined that additional information is needed to support approval in this indication, and Kyowa Hakko Kirin has decided to temporarily withdraw submission for Mogamulizumab use in untreated CCR4-positive ATL from the application.

Company plans to re-file the application for untreated CCR4-positive ATL when additional required information is available. Review of the application in PTCL and CTCL is ongoing.

The current use of "POTELIGIO® Injection 20 mg" for patients with relapsed or refractory ATL is not affected by this change to the content of the approval application.

Kyowa Hakko Kirin is committed to developing innovative therapeutics for treatment of a wide range of diseases, including lymphomas such as ATL, PTCL and CTCL, and contributing to the improvement of patients' quality of life (QOL).


State of Development and Marketing of Mogamulizumab for Cancer

Indication Status Applicable Locations
Relapsed or refractory CCR4-positive ATL Available Japan
Untreated CCR4-positive ATL Now withdrawn Japan
Previously treated ATL Phase 2 trial United States, Europe
Relapsed or refractory CCR4-positive PTCL and CTCL Application filed Japan
Relapsed or refractory CTCL Phase 3 trial United States, Europe, Japan
Previously treated CCR4-positive PTCL Phase 2 trial Europe


About CC chemokine receptor 4 (CCR4)
CCR4 is one of the chemokine receptors involved in leukocyte migration, selectively expressed in type 2 helper T (Th2) cells and regulatory T (Treg) cells. CCR4 is also shown to be over-expressed in certain hematological malignancies.

About adult T-cell leukemia-lymphoma (ATL)
ATL is a peripheral T-cell malignancy and the retrovirus HTLV-1 is thought to be involved in its onset. Estimates show that around 1,150 new cases occur every year in Japan. In Japan ATL is generally treated with combination chemotherapy, such as mLSG15, but there are currently no therapeutic methods with the potential of providing a cure for ATL, although researchers are actively looking into other methods than transplantation. For relapsed/refractory cases, various chemotherapy regimens based on malignant lymphoma therapies are currently used, but an effective treatment method has yet to be established.

About Peripheral T-Cell Lymphoma (PTCL)
Non-Hodgkin lymphomas account for the majority of malignant lymphoma cases and can be broadly divided into disease of B-cell origin and disease of T/natural killer (NK)-cell origin. Disease of T/NK-cell origin can be classified according to the main lesion site into nodal, extranodal, cutaneous, and leukemic disease. PTCL is a general term describing nodal and extranodal disease of T/NK-cell origin.

About Cutaneous T-Cell Lymphoma (CTCL)
CTCL is a rare, low grade type of non-Hodgkin's lymphoma. CTCL is one of the most common forms of T-cell lymphoma. The two most common types of CTCL are mycosis fungoides (MF) and Sézary syndrome (SS). MF does not look the same in all patients and may present as skin patches, plaques, and tumors. SS in an advanced form of MF and includes the presence of malignant lymphocytes in the blood.

News Source : Change to Supplemental Application Seeking Approval of Additional Indication for Mogamulizumab

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