Potential Impact of Accelerated Approval on the Drug Lags for Anticancer Drugs Between the United States and Japan





accelerated approval, anticancer drug, drug lag, oncology, Japan


The term 'drug lag' represents the difference in the timing of drug approval among countries. The impact of accelerated approvals on the drug lag for anticancer drugs between the United States (U.S.) and Japan was evaluated using publicly available information to identify anticancer drugs approved in the U.S. or Japan between January 2006 and March 2017. A logistic regression analysis was conducted to determine the association between the oncology drugs lags and potential factors, including accelerated approval. The median drug lag was 805 days. The drug lag was extended for drugs that were approved in the U.S. under accelerated approval (884 days) compared to the standard approval (606 days). A total of 170 approvals were available for the analysis of drug lags. A multivariate logistic regression analysis revealed that the following factors contributed significantly to the drug lags (p < 0.05): accelerated approval (odds ratio [OR] 4.48), Phase III study (OR 3.69), major cancer (OR 0.38), and international/global development (OR 0.32). Accelerated approval in the U.S. is one of the significant factors that extend the drug lags for anticancer drugs. The current drug development and approval process in Japan may have advantages, however, since a new regulation to reduce drug lag for anticancer drugs, the conditional early approval system, may help minimize drug lags and support decision making not only for regulators but also pharmaceutical companies.



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Potential Impact of Accelerated Approval on the Drug Lags for Anticancer Drugs Between the United States and Japan. (2020). Journal of Regulatory Science, 8, 1-9. https://doi.org/10.21423/JRS-V08NAGASAWA