title: Report on the use of non-clinical studies in the regulatory evaluation of oncology drugs.
abstract: Non-clinical studies are necessary at each stage of the development of oncology drugs. Many experimental cancer models have been developed to investigate carcinogenesis, cancer progression, metastasis, and other aspects in cancer biology and these models turned out to be useful in the efficacy evaluation and the safety prediction of oncology drugs. While the diversity and the degree of engagement in genetic changes in the initiation of cancer cell growth and progression are widely accepted, it has become increasingly clear that the roles of host cells, tissue microenvironment, and the immune system also play important roles in cancer. Therefore, the methods used to develop oncology drugs should continuously be revised based on the advances in our understanding of cancer. In this review, we extensively summarize the effective use of those models, their advantages and disadvantages, ranges to be evaluated and limitations of the models currently used for the development and for the evaluation of oncology drugs.
authors.affiliation: Subcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.|Division of Pathogenic Biochemistry, Department of Bioscience, Institute of Natural Medicine, University of Toyama, Toyama, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Hayakawa
authors.affiliation: Subcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.|Institute of Microbial Chemistry, Microbial Chemistry Research Foundation, Numazu-shi, Japan.
authors.forename: Manabu
authors.initials: M
authors.lastname: Kawada
authors.affiliation: Subcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.|Division of Cancer Immunology, Exploratory Oncology Research and Clinical Trial Center, National Cancer Center, Chiba, Japan.
authors.forename: Hiroyoshi
authors.initials: H
authors.lastname: Nishikawa
authors.affiliation: Subcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.|Division of Molecular and Cellular Medicine, National Cancer Center Research Institute, Tokyo, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Ochiya
authors.affiliation: Subcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.|Division of Gene Regulation, Institute for Advanced Medical Research, School of Medicine, Keio University, Tokyo, Japan.
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Saya
authors.affiliation: Subcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.|Division of Molecular Biotherapy, Cancer Chemotherapy Center, Japanese Foundation for Cancer Research, Tokyo, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Seimiya
authors.affiliation: Subcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.|Division of Cell Biology, Cancer Institute, Japanese Foundation for Cancer Research, Tokyo, Japan.
authors.forename: Ryoji
authors.initials: R
authors.lastname: Yao
authors.affiliation: Subcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.|Department of Pharmacy, Toranomon Hospital, Tokyo, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Hayashi
authors.affiliation: Subcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.|Laboratory Animal Research Center, Institute of Medical Science, The University of Tokyo, Tokyo, Japan.
authors.forename: Chieko
authors.initials: C
authors.lastname: Kai
authors.affiliation: Subcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.|Department of Medicinal Chemistry, Faculty of Pharmaceutical Sciences, Hokkaido University, Sapporo, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Matsuda
authors.affiliation: Subcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.|National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
authors.forename: Tomoki
authors.initials: T
authors.lastname: Naoe
authors.affiliation: Subcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.|Exploratory Oncology Research and Clinical Trial Center, National Cancer Center, Chiba, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Ohtsu
authors.affiliation: Subcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.|Division of Immune Regulation, Institute for Genome Research, Tokushima University, Tokushima, Japan.
authors.forename: Taku
authors.initials: T
authors.lastname: Okazaki
authors.affiliation: Subcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.|Department of Patho-Functional Bioanalysis, Graduate School of Pharmaceutical Sciences, Kyoto University, Kyoto, Japan.
authors.forename: Hideo
authors.initials: H
authors.lastname: Saji
authors.affiliation: Subcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.|Department of Cardiovascular Medicine, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan.
authors.forename: Masataka
authors.initials: M
authors.lastname: Sata
authors.affiliation: Subcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.|Department of Tumor Pathology, Hamamatsu University School of Medicine, Shizuoka, Japan.
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Sugimura
authors.affiliation: Subcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.|Sugiyama Laboratory, RIKEN Innovation Center, RIKEN Cluster for Industry Partnerships, Kanagawa, Japan.
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Sugiyama
authors.affiliation: Subcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.|Department of Breast Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
authors.forename: Masakazu
authors.initials: M
authors.lastname: Toi
authors.affiliation: Subcommittee on Non-clinical Studies, The Science Board to the Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.|Juntendo University School of Medicine, Tokyo, Japan.
authors.forename: Tatsuro
authors.initials: T
authors.lastname: Irimura
mesh_terms: D000818:Animals; D000970:Antineoplastic Agents; D004195:Disease Models, Animal; D055808:Drug Discovery / Q000379:methods*; D006801:Humans; D008495:Medical Oncology / Q000379:methods*; D009369:Neoplasms
chemical_list: D000970:Antineoplastic Agents
keywords: Animal model; cancer; drug development; oncology drug; regulatory science