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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P04-105
November 19, 2004

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

FDA Approves New Drug for the Most Common Type of Lung Cancer Drug Shows Survival Benefit

The Food and Drug Administration (FDA) announced the approval of Tarceva (erlotinib) tablets as a single agent treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), the most common form of lung cancer in the U.S. Tarceva is being approved as a treatment for patients whose cancer has continued to progress despite other treatments, including at least one prior chemotherapy regimen.

Tarceva is a drug that inhibits an enzyme, tyrosine kinase, associated with a Human Epidermal Growth Factor Receptor. The drug has shown improved survival in patients with locally advanced or metastatic NSCLC. Tarceva received "Fast Track" status from FDA during its development.

"FDA believes it is crucial for cancer patients to have many safe and effective treatment options available to them in their battle against this disease" said Dr. Lester M. Crawford, Acting FDA Commissioner. "With the approval of Tarceva thousands of patients with lung cancer will not only have access to another treatment option, but one that extends life."

Safety and efficacy were demonstrated in one randomized trial in 731 patients comparing Tarceva to placebo. The primary endpoint in this trial was survival. The median overall survival was 6.7 months in the Tarceva group compared with 4.7 months in the placebo group.

The mechanism of action by which Tarceva exerts its clinical benefit is not fully understood. However, Tarceva was developed to block growth stimulatory signals in cancer cells. These signals are mediated in part by enzymes called tyrosine kinsases. Tarceva blocks the tyrosine kinase associated with Epidermal Growth Factor Receptor (EGFR).

In about one third of the patients tumor cells were examined to see whether they had high or low levels of EGFR. Among the approximately 55% who had high EGFR the effect on survival was much greater than it was in people whose EGFR levels were low. The relationship will be explored further in the future.

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

FDA reviewed the application for Tarceva utilizing the "rolling review" procedures that are available to new drug applications designated as "Fast Track." In rolling review, FDA starts reviewing specific components of a drug approval application even before all the application components have been submitted to the agency. For Tarceva, the first piece of the application was submitted in January 2004, and the last portion in July 2004.

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 manufactured by OSI Pharmaceuticals Inc., and distributed by Genentech Inc., of South San Francisco, Calif.

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