Report on the use of non‐clinical studies in the regulatory evaluation of oncology drugs

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 evalu...

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Bibliographic Details
Published in:Cancer science 2016-02, Vol.107 (2), p.189-202
Main Authors: Hayakawa, Yoshihiro, Kawada, Manabu, Nishikawa, Hiroyoshi, Ochiya, Takahiro, Saya, Hideyuki, Seimiya, Hiroyuki, Yao, Ryoji, Hayashi, Masahiro, Kai, Chieko, Matsuda, Akira, Naoe, Tomoki, Ohtsu, Atsushi, Okazaki, Taku, Saji, Hideo, Sata, Masataka, Sugimura, Haruhiko, Sugiyama, Yuichi, Toi, Masakazu, Irimura, Tatsuro
Format: Article
Language:English
Subjects:
Animal model
Animals
Antineoplastic Agents
Biology
Cancer
Cancer therapies
Carcinogenesis
Cell division
Disease Models, Animal
Drug development
Drug Discovery - methods
Drugs
Genes
Genetic engineering
Humans
Immune system
Immunosuppressive agents
Medical equipment
Medical Oncology - methods
Medical research
Metastases
Mutation
Neoplasms
Oncology
oncology drug
Pharmaceuticals
Pricing policies
Product development
regulatory science
Studies
Tumors
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Summary: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. This review summarizes the effective use of animal 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.
ISSN:1347-9032
1349-7006
DOI:10.1111/cas.12857