Posted by Michael Wonder on 09 Apr 2019
Daiichi Sankyo’s EZH1/2 dual inhibitor valemetostat (DS-3201) receives SAKIGAKE designation for treatment of patients with relapsed/refractory peripheral T-cell lymphoma from Japan MHLW
9 April 2019 - SAKIGAKE designation will provide development support and accelerated review of valemetostat, an investigational and potential first-in-class EZH1/2 dual inhibitor, for relapsed/refractory peripheral T-cell lymphoma.
Daiichi Sankyo today announced that valemetostat (DS-3201), an investigational and potential first-in-class EZH1/2 dual inhibitor, has received SAKIGAKE Designation for the treatment of adult patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) by the Japan Ministry of Health, Labour and Welfare (MHLW).
The SAKIGAKE Designation System promotes R&D in Japan, driving early practical application for innovative pharmaceutical products, medical devices, and regenerative medicines. As a designated medicine under the SAKIGAKE Designation System, valemetostat will have prioritized consultation, a dedicated review system to support the development and review process, as well as reduced review time from the normal 12 months to 6 months.
