In 2012, Mogamulizumab was launched in Japan under the brand name POTELIGIO Injection 20 mg for the treatment of patients with relapsed or refractory CCR4-positive ATL.
In July 2013, the company had filed SNDA 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).
Consultation with the regulatory agency showed it that additional information is needed to support approval in this indication, and the company has decided to temporarily withdraw submission for Mogamulizumab use in untreated CCR4-positive ATL from the application.
The company also intends to re-submit the application for untreated CCR4-positive ATL when additional required information is available.
Review of the application in PTCL and CTCL is ongoing and the change to the content of the approval application will not affect the current use of ‘POTELIGIO Injection 20 mg’ for patients with relapsed or refractory ATL.
The company mainly develops new therapeutics to treat wide range of diseases, including lymphomas such as ATL, PTCL and CTCL, and contributing to the improvement of patients’ quality of life (QOL).