Daiichi Sankyo files for Japanese approval of teserpaturev

Japanese drugmaker Daiichi Sankyo (TYO: 4568) says it has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labor and Welfare (MHLW) for teserpaturev (G47∆), an oncolytic virus, for the treatment of patients with malignant glioma.

Daiichi Sankyo is collaboratively developing teserpaturev (formerly DS-1647) with Dr Tomoki Todo, Professor at the Institute of Medical Science, University of Tokyo. The Japan NDA submission is based on results of a single-arm Phase II clinical trial conducted by Dr Todo at the University of Tokyo in patients with residual or recurrent glioblastoma tumors, which met its primary endpoint for one-year survival rate.

Daiichi Sankyo will continue to work with the University of Tokyo and with regulatory authorities to safely and expeditiously develop teserpaturev as the first potential oncolytic virus therapy for patients in Japan with malignant gliomas who are in need of new treatment options.

Teserpaturev received Orphan Drug designation in 2017 and SAKIGAKE designation in 2016 from the Japan MHLW for the treatment of patients with malignant glioma.