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. 2023 Dec;16(12):2665-2674.
doi: 10.1111/cts.13660. Epub 2023 Oct 17.

Trends in oncology drug lags in Japan from 2001 to 2020: A cross-sectional study

Hideki Maeda  1 , Asuka Hara  1 , Momoka Ofuchi  1 , Riko Shingai  1 , Toshihiro Misumi  2 , Yuna Murai  1
Affiliations

Trends in oncology drug lags in Japan from 2001 to 2020: A cross-sectional study

Hideki Maeda et al. Clin Transl Sci. 2023 Dec.

Abstract

Anticancer drugs are essential in the treatment of serious diseases, but their applications are limited by drug lags. This study investigated the characteristics of anticancer drugs approved in Japan over the past 20 years and compared the drug lag trends between Japan and the US. We assessed the changes in drug lag between Japan and the US and the factors affecting the drug lags using publicly available data for anticancer drugs approved in Japan from January 2001 to December 2020. A total of 299 anticancer drugs were approved in Japan in the last 20 years. The approval lag median between the US and Japan was 498 days (16.6 months), peaking in 2002, and decreasing annually thereafter. The minimum approval lag was 173.5 days (5.7 months) in 2018. Multivariate regression analysis revealed that "global simultaneous strategy," "catch-up strategy," and "immunotherapy" are major factors shortening the drug lag. In the past decade, 226 anticancer drugs were approved in Japan. The drug lag for anticancer drugs between Japan and the US peaked in 2002, after which it declined sharply to less than a year. However, the lag was shortest in 2018.

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Conflict of interest statement

The authors declared no competing interests regarding this work.

Figures

FIGURE 1
FIGURE 1
Changes in drug type, clinical development strategy, and treatment lines for approved oncology drugs from 2001 to 2020 in Japan. (a) Mode of action of the anticancer drug. (b) Treatment lines in each indication. (c) Strategy for clinical development. (d) Use of foreign data in the Japanese approval process.
FIGURE 2
FIGURE 2
Changes in lags between the US and Japan over 5‐year periods from 2001 to 2020 for oncology drugs. The horizontal line in each box shows the median. The x‐axis shows the average. The line at the top edge and bottom edge of each box shows the 75th percentile and the 25th percentile, respectively. The upper and lower limit of the vertical line is the maximum value and minimum value, respectively.
FIGURE 3
FIGURE 3
Annual changes in approval lag between the US and Japan from 2001 to 2020 for oncology drugs. The horizontal line in each box shows the median. The x‐axis shows the average. The line at the top edge and bottom edge of each box shows the 75th percentile and the 25th percentile, respectively. The upper and lower limit of the vertical line is the maximum value and minimum value, respectively.
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