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Lessons from gefitinib-induced interstitial lung disease in Japan: Problems in approval, pharmacovigilance, and regulatory decision-making procedures

Tsutomu NISHIMURA1, Harue TADA1, Masatsugu NAKAGAWA1, Satoshi TERAMUKAI1, Shigeyuki MATSUI2, Masanori FUKUSHIMA1

  1. 1Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan.
  2. 2Pharmacoepidemiology, Graduate School of Public Health, Kyoto University, Kyoto, Japan.

Volume 4, Issue 4 · pp. 168–178 · PUBLISHED 2026 · DOI:

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ABSTRACT

Objective: The objective of this study was to identify problems in the approval, pharmacovigilance, and post-approval regulatory decision-making procedures involving gefitinib and to propose countermeasures to prevent further drug-induced suffering in Japan in the future. Methods: We comprehensively reviewed reports regarding gefitinib published during the period from 2000 to 2006 by regulatory agencies, the manufacturer of the gefitinib-containing drug, cancer clinical study groups, and a scientific society. Results: We identified the following major problems in the approval, pharmacovigilance, and regulatory decision-making procedures: 1) the results of animal experiments and pre-marketing clinical trials, and reports of adverse drug reactions from other countries were not properly reflected in the label; 2) indications for the drug were expanded without strict evaluation of the external validity of pre-marketing clinical trials; and 3) despite many serious cases of interstitial lung disease (ILD) being spontaneously reported, well-designed post-marketing surveillance was not immediately performed. Conclusions: We propose a mandatory total registry of all drug users and surveillance (i.e. a prospective outcome study) as one of the rational solutions for preventing further drug-induced suffering in Japan.

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    NISHIMURA, T., TADA, H., NAKAGAWA, M., TERAMUKAI, S., MATSUI, S., & FUKUSHIMA, M. (2026). Lessons from gefitinib-induced interstitial lung disease in Japan: Problems in approval, pharmacovigilance, and regulatory decision-making procedures. Pharmacy Practice, 4(4), 168–178.