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Tarceva Approved for Lung Cancer
Drug Extends Survival
Article date: 2004/11/19

Patients with the most common type of lung cancer now have another treatment option: erlotinib (marketed as Tarceva). The US Food and Drug Administration has approved the drug for patients with non-small cell lung cancer that has not responded to other treatments, including at least one round of chemotherapy.

The drug has been shown to help patients live longer. In a study of 731 patients with locally advanced and metastatic disease, those who took Tarceva lived about 6.7 months, while those given a placebo lived just 4.7 months. Patients who had never smoked saw the greatest benefit. The results in patients who smoked are less certain.

Although the survival benefit seems small, it is significant to both patients and their loved ones.

Lung cancer kills more people in the US every year than any other cancer. About 160,440 Americans are expected to die from it in 2004. The disease is very difficult to detect and in most people is not found until it has already spread to lymph nodes or other organs. Nearly 60% of people who develop lung cancer die within a year of their diagnosis. Only about 17% live 5 years beyond their diagnosis.

"Physicians will now be able to offer patients a new therapy that has been proven to increase survival and that is different from traditional cytotoxic chemotherapy treatment," Alan Sandler, MD, medical director of the Thoracic Oncology Department at Vanderbilt University, said in a statement.

In the study, the most common side effects were rash, diarrhea, nausea, and vomiting. Tarceva can also cause a potentially deadly lung problem called interstitial lung disease, but this side effect is rare, affecting less than 1% of patients. The drug can harm a developing fetus, so Tarceva is not recommended for pregnant women.

Tarceva is a pill that patients take daily. The drug blocks a signaling pathway that tumors need to grow. It is also being tested against pancreatic cancer. Genentech and OSI Pharmaceuticals manufacture the drug.


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