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

Yoshihiro Hayakawa, Manabu Kawada, Hiroyoshi Nishikawa, Takahiro Ochiya, Hideyuki Saya, Hiroyuki Seimiya, Ryoji Yao, Masahiro Hayashi, Chieko Kai, Akira Matsuda, Tomoki Naoe, Atsushi Ohtsu, Taku Okazaki, Hideo Saji, Masataka Sata, Haruhiko Sugimura, Yuichi Sugiyama, Masakazu Toi, Tatsuro Irimura

Research output: Contribution to journalArticle

1 Citation (Scopus)

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. 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.

Original languageEnglish
Pages (from-to)189-202
Number of pages14
JournalCancer science
Volume107
Issue number2
DOIs
Publication statusPublished - 2016 Feb 1

Keywords

  • Animal model
  • Cancer
  • Drug development
  • Oncology drug
  • Regulatory science

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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  • Cite this

    Hayakawa, Y., Kawada, M., Nishikawa, H., Ochiya, T., Saya, H., Seimiya, H., Yao, R., Hayashi, M., Kai, C., Matsuda, A., Naoe, T., Ohtsu, A., Okazaki, T., Saji, H., Sata, M., Sugimura, H., Sugiyama, Y., Toi, M., & Irimura, T. (2016). Report on the use of non-clinical studies in the regulatory evaluation of oncology drugs. Cancer science, 107(2), 189-202. https://doi.org/10.1111/cas.12857