Daiichi Sankyo Company, Limited announced that it has received conditional and time-limited approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for DELYTACT® (teserpaturev/G47), an oncolytic virus, for the treatment of patients with malignant glioma. DELYTACT previously received SAKIGAKE Designation and Orphan Drug Designation from the MHLW for this indication and is now the first oncolytic virus to be approved in any region of the world for treatment of malignant glioma or any type of primary brain cancer. Daiichi Sankyo has been collaboratively developing DELYTACT with Dr. Tomoki Todo of the Institute of Medical Science, The University of Tokyo, and is the Marketing Authorization Holder of DELYTACT in Japan. The approval of DELYTACT in Japan is based on results of a single-arm phase 2 clinical trial evaluating DELYTACT in patients with residual or recurrent glioblastoma, the most common and aggressive form of malignant glioma. 1 The trial met its primary endpoint for one-year survival rate in an interim analysis. Results of the study will be submitted for publication by Dr. Todo.