Pharma Focus Asia

DELYTACT®Oncolytic Virus G47∆ Approved in Japan forTreatment of Patients with Malignant Glioma

Monday, June 14, 2021

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today 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 Todoof the Institute of Medical Science, The University of Tokyo, andis the Marketing Authorization Holder of DELYTACT in Japan.

The approval of DELYTACT in Japan is based on results of asingle-arm phase 2 clinical trial evaluating DELYTACT in patients with residual or recurrent glioblastoma, the most common and aggressive form of malignant glioma. The trial met its primary end point for one-year survival rate in an interim analysis. Results of the study will be submitted for publication by Dr. Todo.

“With the approval of DELYTACT in Japanwe can now offer the first-ever oncolytic virus therapy option to patients with glioblastoma and other malignant gliomasthat are not controlled with currently available treatments,” said Wataru Takasaki, PhD, Executive Officer, Head of R&D Division in Japan, Daiichi Sankyo. “DELYTACT is the fourth oncology medicine to be approved in Japan for Daiichi Sankyo over the past two years and we are grateful for the opportunity to collaborate with Dr. Todo to deliver this truly innovative treatment modality to patients and physicians in Japan.”

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