Iressa, FDA Approves Drug for Lung Cancer (cont.)

"An essential part of our accelerated approval process is the further study of the new treatment after it is on the market," said Dr. McClellan. "In the case of Iressa, studies are needed to confirm clinical benefit, understand better which patients benefit, and evaluate long-term safety."

Common side effects reported with Iressa in clinical trials were nausea, vomiting, diarrhea, rash, acne, and dry skin. Iressa may cause fetal harm when administered to pregnant women.

A significant safety concern associated with Iressa emerged just after the ODAC meeting. Reports from Japan described the occurrence of serious and sometimes fatal interstitial lung disease (ILD) in patients treated with Iressa. The FDA extended its review of Iressa by three months to review these reports. After careful review of information from all sources, including a comprehensive analysis of updated toxicity information from clinical trials and the Iressa expanded access program, involving approximately 23,000 patients, FDA determined that the incidence of ILD was approximately 2% in the Japanese experience and approximately 0.3% in the United States expanded access program, with about 1/3 of affected patients dying from this toxicity. FDA believes that this rare but serious toxicity of Iressa does not outweigh the benefits demonstrated in patients with advanced NCSLC.

FDA reviewed the application for Iressa utilizing the "rolling review" procedures that are available to new drug applications designated as "Fast Track." In rolling review, FDA starts reviewing components of a drug approval application even before all the data have been submitted to the agency. For Iressa, the first piece of rolling application was submitted on July 30, 2001, and the last portion on August 5, 2002.

Cancer of the lung and bronchus is the second most common cancer among both men and women and is the leading cause of cancer death in both sexes in the Unites States. NSCLC is the most common type of lung cancer, accounting for almost 80% of lung cancers.

The drug will be marketed by its manufacturer, AstraZeneca LP of Wilmington, Del.

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Last Editorial Review: 6/20/2005