Anticancer drug Tarceva slows lung cancer

Drug News
Anticancer drug Tarceva slows lung cancer - new study
By David Liu, Ph.D.
Nov 8, 2008 - 1:33:26 PM

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OSI Pharmaceuticals Inc. and its partners said Friday the results of a new study showed the drug Tarceva or erlotinib effectively slows the progression of lung cancer when given immediately after chemotherapy.

The study called Saturn will be released to an upcoming medical conference and later will be submitted to the Food and Drug Administration to get the drug approved for use in patients with earlier stages of lung cancer.

Tarceva as a single agent treatment was already approved in 2004 by the FDA to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), the most common form of lung cancer in the U.S in cases other treatments have failed to stop progression of the disease.

Tarceva works by inhibiting an enzyme, tyrosine kinase, associated with a Human Epidermal Growth Factor Receptor. The drug has in an early trial improved survival in patients with locally advanced or metastatic NSCLC.

In that trial, safety and efficacy were demonstrated 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, according to the FDA.

Tarceva is not a wonder drug. It failed to prolong the lives of patients in other trials when used along with Avastin, a cancer drug made by Genentech. Genentech and Roche Holdings are partners of OSI in the development of marketing of Tarceva.

The new Saturn study by Roche involved 889 patients enrolled at 160 sites worldwide, according to a press release issued on Nov 6 by OSI and Genentech.

"We believe that Tarceva as a once-a-day oral therapy, which has a well-established safety profile, may be well-suited as a maintenance therapy in the first-line setting following chemotherapy," said Gabriel Leung, President, OSI Oncology.

"We are excited about the prospect that for the first time patients may have a treatment alternative that is different from traditional chemotherapy and extends the time patients live without their cancer progressing following initial treatment."

"We are pleased by the findings as they represent another step forward in our hopes of providing more options to patients throughout their battle with lung cancer," said Hal Barron, M.D., Genentech's senior vice president, Development and chief medical officer.

The drug like many others does not come free of side effects. According to the document issued by FDA earlier, Tarceva can cause severe or non-stop diarrhea, nausea, loss of appetite, or vomiting, new or worse trouble breathing or cough, tiredness, inflammation of the mouth, rash, itching, dry skin, and eye irritation.

The FDA warned that some patients taking Tarceva developed a serious and life-threatening lung disease called interstitial lung disease and women who are pregnant or breastfeeding should not take this drug. Pregnancy should be avoided during Tarceva therapy and for two weeks after stopping use of the drug.

Analysts said Tarceva could bring the manufacturers and partners more than $1 billion a year in global sales. On Friday, OSI shares rose $5.25 to $40.65, according to newsdayreported.

An estimated 215,000 Americans will be diagnosed with lung cancer and 162,000 will die of this disease in 2008, according to the American Cancer Society (ACS). The disease is the single largest cause of death from cancer responsible for about 30 percent of cancer deaths among men and women in the United States.