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

Author: AsanoJunichi, FujiwaraYasuhiro, HondaFutaba, MaruyamaYoshiaki, NodaShinichi, OkuraNarumi, SakuraiAkira, TakagiToshinori

Paper Details 
Original Abstract of the Article :
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 bot...See full text at original site
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引用元:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10400161/

データ提供:米国国立医学図書館(NLM)

Delytact Injection for Malignant Glioma

In the world of medicine, finding solutions for complex diseases like malignant glioma is like searching for a hidden oasis in a vast desert. This research focuses on the regulatory landscape of a novel oncolytic virus therapy, Delytact Injection, which uses a genetically engineered herpes simplex virus to target and destroy cancerous cells. The study highlights the approval process in Japan, emphasizing the need for post-market surveillance to ensure effectiveness and safety. This is like navigating a treacherous desert path – it's crucial to have clear checkpoints and ongoing monitoring to ensure a safe journey.

Delytact Injection: A New Hope?

The study reveals that Delytact Injection demonstrated some efficacy in a phase II clinical trial. While the results were promising, further research is needed to solidify its role in treating malignant glioma. It's like discovering a spring in the desert, but we need to ensure it's a sustainable source of water before we declare it a true oasis.

Navigating the Treatment Landscape

The approval of Delytact Injection under a conditional and time-limited scheme underscores the importance of ongoing research and careful evaluation. This approach reflects the cautious optimism of the medical community – it's like taking a step forward in the desert, but with a watchful eye on the surrounding landscape.

Dr.Camel's Conclusion

This study offers a glimpse into the exciting world of oncolytic virus therapy for malignant glioma. While Delytact Injection holds promise, it's crucial to continue researching and monitoring its long-term effects. After all, a successful journey through the desert requires perseverance, careful observation, and a willingness to adapt to the ever-changing landscape.

Date :
  1. Date Completed 2023-08-07
  2. Date Revised 2023-08-07
Further Info :

Pubmed ID

36917020

DOI: Digital Object Identifier

PMC10400161

Related Literature

SNS
PICO Info
in preparation
Languages

English

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