The Food and Drug Administration (FDA) has announced the accelerated approval of gefitinib (Iressa^TM, 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).

Women with lung cancer survive slightly longer than men with the disease, respond differently to at least one cancer drug, and show higher levels of tobacco-induced genetic damage in their lungs, say researchers from Memorial Sloan-Kettering Cancer Center in New York and Northwestern University in Chicago.

Some differences may stem from the effects of estrogen, whether naturally occurring or taken as a drug, and the scientists said more women should be included in studies of lung cancer to find out whether particular methods of treatment, prevention, and detection are best suited to them.

Nearly 80% of cases of lung cancer in women were the result of smoking. From 1930 to 1997, as more women began smoking, their death rate from lung cancer rose by 600%. Since the 1960s, smoking rates for American men have decreased by nearly 50% and by 25% for women.

The disease kills more women in the U.S. than any other cancer—as many as breast cancer and all gynecological cancers combined.

It is not known whether men and women who smoke are equally susceptible to lung cancer. Women are more likely to have adenocarcinoma, the most common lung cancer among non-smokers. Some studies suggest that natural or synthetic estrogen might stimulate adenocarcinomas. Women who smoke have a more active version of a gene that makes chemicals in cigarette smoke more harmful to cells. Estrogen might make that gene more active.

The FDA has approved erlotinib (Tarceva,™ OSI/Genentech) to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) for patients whose disease progressed despite at least one chemotherapy regimen.

The tablet, taken daily, blocks signals that stimulate growth in cancer cells by inhibiting an enzyme associated with epidermal growth factor receptor.

The FDA based its approval on a randomized phase 3 pivotal trial in which treated patients survived for a median of 6.7 months and placebo patients survived 4.7 months. After one year, 31.2% of the treated patients were alive, compared with 21.5% of the placebo patients.

Preliminary results from a large, randomized clinical trial of patients with previously untreated advanced non-squamous, non-small cell lung cancer (NSCLC) show that those who received bevacizumab (Avastin™, Genentech), combined with standard chemotherapy (paclitaxel plus carboplatin), lived longer than patients who received the same chemotherapy without bevacizumab. A humanized monoclonal antibody, beva-cizumab binds to and inhibits vascular endothelial growth factor (VEGF), a protein that is essential for tumor angio-genesis.

The difference in survival times was statistically significant. Patients with squamous cell carcinoma of the lung were not included in the study because previous clinical experience suggested that patients with this type of NSCLC had a higher risk of serious pulmonary bleeding after bevacizumab therapy. Patients with a history of hemoptysis (coughing up blood) were also excluded.

The FDA has approved bevacizumab (Avastin, Genentech) for use in combination with carboplatin and paclitaxel chemotherapy for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer, the most common type of lung cancer.

In a phase 3 study, bevacizumab plus chemotherapy resulted in a 25% improvement in overall survival, compared with chemotherapy alone.

In 2004, the FDA approved the drug for the first-line or second-line treatment of metastatic colon or rectal carcinoma in combination with IV 5-fluorouracil-based chemotherapy.