Gefitinib: phase II and III results in advanced non-small cell lung cancer.

Several novel biologic agents have been designed to specifically inhibit different aspects of tumor growth and progression. The epidermal growth factor receptor has a pivotal role in tumor biology and thus is an important anticancer target. Gefitinib is an orally active epidermal growth factor receptor tyrosine kinase inhibitor that blocks signal-transduction pathways implicated in the proliferation and survival of cancer cells. Clinically meaningful antitumor activity, symptom relief, and a good tolerability profile have been shown in phase II trials of gefitinib monotherapy in patients with recurrent non-small cell lung cancer. Clinical trials are ongoing to investigate further applications of this novel agent for the treatment of non-small cell lung cancer.