Kyowa Hakko Kirin Withdraws Submission For Mogamulizumab Additional Indication In Japan
Kyowa Hakko Kirin (KHK) has announced its decision to withdraw part of an application of an additional indication for its cancer drug mogamulizumab in Japan. The company said additional information is required and the withdrawal is only temporary.
The company submitted a supplemental new drug application (NDA) for mogamulizumab on July 19, 2013, for the additional indication of the drug for untreated CC chemokine receptor 4 (CCR4) positive adult T-cell leukemia-lymphoma (ATL), cutaneous T-cell lymphoma (CTCL) and relapsed or refractory CCR4-positive peripheral T-cell lymphoma (PTCL). Through consultation with the regulatory agency, the company decided to withdraw its application for mogamulizumab use in untreated CCR4-positive ATL due to the need for additional information to support approval.
Mogamulizumab is a cancer drug marketed by KHK under the brand name Poteligio (injection 20 mg). The drug is used for treatment of patients with refractory or relapsed CCR4-positive ATL. CCR4 is a chemokine receptor connected to leukocyte migration and observed to be over-expressed in specific hematological malignancies. ATL is known to be a peripheral T-cell malignancy with no established curative therapeutic method. Around 1,150 new ATL cases occur in Japan every year.
PTCL is an umbrella term describing nodal and extranodal disease of T/natural killer (NK) cell origin, often observed in non-Hodgkin lymphomas. CTCL is classified as a rare, low-grade type of non-Hodgkin’s lymphoma and one of the most common T-cell lymphoma forms.
Poteligio is currently indicated for relapsed or refractory CCR4-positive ATL. The drug is undergoing separate Phase II trials for previously treated ATL and CCR4-positive PCTL. Phase III trial for relapsed or refractory CTCL is ongoing. Kyowa has successfully filed for approval for Poteligio use in relapsed or refractory CCR4-positive PTCL and CTCL in Japan.
KHK said it has plans to file the application for additional indication a second time when required information has been satisfied.
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