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Recent trends for drug lag in clinical development of oncology drugs in Japan: does the oncology drug lag still exist in Japan?

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Abstract

Background

This study exhaustively and historically investigated the status of drug lag for oncology drugs approved in Japan.

Methods

We comprehensively investigated oncology drugs approved in Japan between April 2001 and July 2014, using publicly available information. We also examined changes in the status of drug lag between Japan and the United States, as well as factors influencing drug lag.

Results

This study included 120 applications for approval of oncology drugs in Japan. The median difference over a 13-year period in the approval date between the United States and Japan was 875 days (29.2 months). This figure peaked in 2002, and showed a tendency to decline gradually each year thereafter. In 2014, the median approval lag was 281 days (9.4 months). Multiple regression analysis identified the following potential factors that reduce drug lag: “Japan’s participation in global clinical trials”; “bridging strategies”; “designation of priority review in Japan”; and “molecularly targeted drugs”.

Conclusions

From 2001 to 2014, molecularly targeted drugs emerged as the predominant oncology drug, and the method of development has changed from full development in Japan or bridging strategy to global simultaneous development by Japan’s taking part in global clinical trials. In line with these changes, the drug lag between the United States and Japan has significantly reduced to less than 1 year.

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Acknowledgments

The authors thank Kentaro Takeda for his statistical support and advice.

Conflict of interest

Hideki Maeda is an employee of Astellas Pharma Inc. Tatsuo Kurokawa has no conflict of interest.

Author information

Authors and Affiliations

  1. Division of Drug Development and Regulatory Science, Graduate School of Pharmaceutical Sciences, Keio University, 1-5-30, Shibakoen, Minato-ku, Tokyo, 105-8512, Japan

    Hideki Maeda & Tatsuo Kurokawa

  2. Oncology, Clinical Development Department, Global Development, Astellas Pharma Inc., 2-5-1, Nihonbashi-honcho, Chuo-ku, Tokyo, 103-8411, Japan

    Hideki Maeda

Authors
  1. Hideki Maeda
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  2. Tatsuo Kurokawa
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Correspondence to Hideki Maeda.

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Maeda, H., Kurokawa, T. Recent trends for drug lag in clinical development of oncology drugs in Japan: does the oncology drug lag still exist in Japan?. Int J Clin Oncol 20, 1072–1080 (2015). https://doi.org/10.1007/s10147-015-0825-4

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  • DOI: https://doi.org/10.1007/s10147-015-0825-4

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