< Relevant articles > Please go to PubMed here. Review of Sakigake Designation Products: Oncolytic Virus Therapy with Delytact Injection (Teserpaturev) for Malignant Glioma. Oncologist 28, 664-70 (2023). 10.1093/oncolo/oyad041 < Backgrounds > In June 2021, the Ministry of Health, Labour and Welfare approved Delytact Injection (generic name: teserpaturev) (hereinafter, “this drug”) as a regenerative medical product for oncolytic virus therapy for the first time in the world. We believe that sharing this review experience internationally will contribute to the appropriate development and evaluation of regenerative medical products. < Outline> The active substance of this product is a genetically engineered herpes simplex virus type 1 (strain F) in which the α47 gene and both copies of the γ34.5 gene have been deleted and the infected cell protein 6 (ICP6) gene has been inactivated by the insertion of the lacZ gene from Escherichia coli. The direct injection of this product in the tumor of patients with cytocidal effect, and 2) the administration leads to induction of tumor-responsive T cells, which activates antitumor immunity. With this product, a non-GCP-compliant Japanese phase I/II study in patients who were refractory to radiotherapy was conducted, and a GCP-compliant Japanese phase II study (Study GD01) was conducted in patients with glioblastoma who had residual or recurrent tumors after radiotherapy with concomitant temozolomide. The tumor response is shown in the table below. Some patients with rapidly-progressing glioblastoma, in whom long-term stable disease is extremely rare, remained stable for a long time in the GD01 study. Therefore, we determined that this drug can be effective to a certain level. However, since the information is limited at present, we consider it appropriate to continuously evaluate and confirm the efficacy of this drug after the approval. The product was approved with 3 approval conditions, including a strict post-marketing evaluation within the period (7 years) after these reviews. Office of Cellular and Tissue-based Products, Yoshiaki Maruyama 24 Maruyama, Y., Sakurai, A., Noda, S., Fujiwara, Y., Okura, N., Takagi, T., Asano, J. & Honda, F. Regulatory Issues: PMDA - malignant glioma in the following process is expected to prolong the survival of patients with malignant glioma: 1) The mutant virus selectively replicates in tumor cells and destroys the infected cells through the replication process, exerting a PMDA - Review of Sakigake Designation Products: Oncolytic Virus Therapy with Delytact Injection (Teserpaturev) for Malignant Glioma
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