This past summer, the United States joined more than 60 countries worldwide in approving the epidermal growth factor receptor (EGFR) inhibitor gefitinib for the treatment of patients with non-small-cell lung cancer (NSCLC) who harbor certain EGFR mutations. The approval marked “restoration of fortune” for the drug, which originally received accelerated approval from the US Food and Drug Administration (FDA) in 2003 for the treatment of advanced NSCLC after progression on platinum doublet chemotherapy and docetaxel but was voluntarily withdrawn from the market after subsequent confirmatory randomized trials failed to verify a survival benefit.
Click on the PDF icon at the top of this introduction to read the full article.