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While the 5-year survival rates of NSCLC range from approximately 20% for patients with stage 1 disease to 5% for those with metastatic disease, a better prognosis is associated with the adenocarcinoma subtype. Gefitinib is an orally active epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). Gefitinib is an effective therapy for patients with advanced, recurrent NSCLC harboring EGFR exon 19 deletions or exon 21 L858R point mutations. Gefitinib was approved by the United States Food and Drug Administration (FDA) in July 2003 for the treatment of patients with locally advanced or metastatic EGFR-mutated, non-small cell lung cancer (NSCLC). Gefitinib is also approved for the treatment of advanced adenocarcinoma of the lung in patients who have never been treated with chemotherapy for their disease. Treatment of advanced disease with gefitinib has resulted in a substantial response rate with tolerable toxicities. 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