Experiences from Japan: conditional and time-limited approval – an early approval scheme for regenerative medical products

Maruyama, Yoshiaki; Kasai, Masaki; Fujiwara, Yasuhiro; Asano, Junichi; Jotatsu, Yasushi

doi:10.18609/cgti.2019.064

Cited by 1 publication

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“…The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act) provides the option of a new approval scheme “conditional and time-limited approval,” only for regenerative medical products to achieve early practical application. 13 , 14 Based on the submitted data, the PMDA has concluded that the product is expected to have a certain level of efficacy in the treatment of malignant glioma and that the product has acceptable safety. Given the limited information at present, the applicant should continue evaluating the efficacy of the product even after the market launch.…”

Section: Discussionmentioning

confidence: 99%

Regulatory Issues: PMDA – Review of Sakigake Designation Products: Oncolytic Virus Therapy with Delytact Injection (Teserpaturev) for Malignant Glioma

et al. 2023

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In June 2021, the Ministry of Health, Labor and Welfare approved Delytact Injection as a regenerative medical product for oncolytic virus therapy. The active substance of Delytact Injection is teserpaturev, 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. Delytact Injection, when intratumorally administered to patients with malignant glioma, is expected to exert the following effects: (1) the mutant virus selectively replicates in tumor cells and destroys the infected cells through the replication process, exerting a cytocidal effect, and (2) the administration leads to induction of tumor-responsive T cells, which activates antitumor immunity and thus prolongs the survival of patients with malignant glioma. A Japanese phase II study (Study GD01) was conducted in patients with glioblastoma who had residual or recurrent tumors after radiotherapy with concomitant temozolomide. In Study GD01, however, stable disease continued for an extended period in some patients with glioblastoma. Hence, Delytact Injection is expected to be effective to a certain level. In line with this, Delytact Injection has been approved as an option for the treatment of malignant glioma, with one of the 3 approval conditions including conducting a use-results comparison survey and resubmission of the marketing authorization application within the granted time period of 7 years, under the conditional and time-limited approval scheme described in Article 23–26 of Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.

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Section: Discussionmentioning

confidence: 99%