Regional Disparity in First-in-Class Anticancer Drug Development in the US, EU, and Japan

Yoshitsugu Hino, Miu Okada, Christine Erikstrup Hallgreen, Marie Louise De Bruin, Randell E. Doty, Naoki Matsumaru, Katsura Tsukamoto*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

A cancer diagnosis is devastating for both patients and their caregivers. With high morbidity and mortality, cancer is a serious disease area with unmet medical needs. Thus, innovative anticancer drugs are in high demand worldwide but are unequally available. Our study focused on first-in-class (FIC) anticancer drugs and investigated their actual development situation in the United States (US), European Union (EU), and Japan over the last two decades to obtain fundamental information for understanding how the aforementioned demands are met, especially to eliminate drug lags among regions. We identified FIC anticancer drugs using pharmacological classes for the Japanese drug pricing system. Most FIC anticancer drugs were first approved in the US. The median approval time for anticancer drugs in new pharmacological classes during the last two decades in Japan (5072d) was significantly different (p=0.043) from that in the US (4253d), though it was not significantly different from that in the EU (4655d). Submission and approval lags between the US and Japan were more than 2.1 years, and those between the EU and Japan were more than 1.2 years. However, those between the US and the EU were less than 0.8 years. The development rate of FIC anticancer drugs in Japan is slower than in other regions. Even among developed countries, FIC anticancer drug lags exist. Considering the high impact of FIC anticancer drugs on society worldwide, we should work together to reduce drug lag among regions using an improved international cooperative framework.

Original languageEnglish
Pages (from-to)700-706
Number of pages7
JournalBiological and Pharmaceutical Bulletin
Volume46
Issue number5
Early online date4 Mar 2023
DOIs
Publication statusPublished - May 2023

Keywords

  • anticancer
  • drug development
  • drug lag
  • first-in-class
  • regulatory policy

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