PMDAにおけるがん免疫療法における非臨床安全性評価

野中 瑞穂

doi:10.14869/toxpt.47.1.0_S3-2

Annual Meeting of the Japanese Society of Toxicology

The 47th Annual Meeting of the Japanese Society of Toxicology

Session ID : S3-2

DOI https://doi.org/10.14869/toxpt.47.1.0_S3-2

Conference information

Host: The Japanese Society of Toxicology

Name : The 47th Annual Meeting of the Japanese Society of Toxicology

Date : 2020 -

Symposium 3

Preclinical safety evaluation of cancer immunotherapy products at PMDA

*Mizuho NONAKA

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CONFERENCE PROCEEDINGS FREE ACCESS

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Abstract

Recently, various modalities of cancer immunotherapy products have been developed, such as antibody, peptide vaccine, gene therapy product which expresses the cancer antigen in vivo, and chimeric antigen receptor (CAR)-engineered T cells. Preclinical safety evaluation of these products should be conducted on case-by-case basis and is delineated in “Guidance on cancer immunotherapy development” (PSFB/ELD Notification No.0308-1).

In this presentation, our preclinical consideration for cancer immunotherapy products will be provided based on our experience.

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