EGFR Inhibitors (Gefitinib, Erlotinib, Afatinib, and Osimertinib)

Gefitinib is the first molecular-targeted treatment drug for lung cancers, and because many markedly effective cases were reported in the clinical development step, the drug had been highly anticipated. The drug was approved on July 5, 2002, was put into practice first in Japan, and about 19,000 persons had used gefitinib by December of the year. However, soon after the release, 13 patients died after the appearance of drug-induced pulmonary disease and on October 15, 2002, emergency safety information was released. Subsequently, suggestions that this problem may have resulted from handling at the developmental step became contentious. Later, the appearance of drug-induced interstitial pneumonia was recognized to appear in a frequency similar to that of other anticancer drugs, and a court ruled that the appearance of serious drug-induced interstitial pneumonia at a certain level of probability was not predictable. However, through this history, we have recognized the importance of informed consent about the efficacy, safety, and toxicities in developing subsequent medicinal products.