Delytact scores a first with Japanese approval for malignant glioma

Japanese drugmaker Daiichi Sankyo (TYO: 4568) says it has received conditional and time-limited approval from the Japan Ministry of Health, Labor and Welfare (MHLW) for Delytact (teserpaturev/G47∆), an oncolytic virus, for the treatment of patients with malignant glioma.

Delytact previously received SAKIGAKE and Orphan Drug designations 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.

Continued approval for this indication may be contingent upon verification and description of clinical benefit and safety in a post-market comparative clinical study. Delytact is not approved for any use outside of Japan.