Gefitinib Approved for Lung Cancer

The Food and Drug Administration (FDA) has announced the accelerated approval of gefitinib (IressaTM, Astra-Zeneca) tablets as a single-agent treatment for patients with advanced non-small cell lung cancer (NSCLC), the most common form of lung cancer in the U.S. Cancer of the lung and bronchus is the leading cause of cancer death in men and women in the U.S. NSCLC accounts for almost 80% of lung cancers.

The drug is intended for patients whose cancer has continued to progress despite chemotherapy with platinum and docetaxel (Taxotere®, Aventis), the two drugs that are currently the standard of care for this disease.

The drug was developed to block growth stimulatory signals in cancer cells. These signals are mediated, in part, by enzymes called tyrosine kinases. The drug blocks several of these tyrosine kin-ases, including one associated with epidermal growth factor receptor (EGFR).