Re: Tarceva: New Drug Against Lung Cancer

From: J (quad_at_privacy.net)
Date: 11/21/04 

Date: Sun, 21 Nov 2004 18:41:16 -0500

http://www.fda.gov/bbs/topics/news/2004/NEW01139.html
 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 kin sases. 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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