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New and Emerging Treatments in Lung Cancer

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Tarceva

Generic drug name:

erlotinib

Brand/trade name:

Tarceva

Manufactured by:

OSI Pharmaceuticals and Genentech Inc.

FDA approval:

April 2010 in the maintenance setting locally advanced or metastatic non-small cell lung cancer that has not progressed after four cycles of platinum-based first line chemotherapy

November 2004* to treat advanced non-small cell lung cancer that has failed to respond to other therapy

Type of drug:

Targeted Therapy (oral)

Overview:
Tarceva is one of a new class of cancer treatments known as targeted therapies. Tarceva is designed to block a particular protein, the epidermal growth factor receptor (EGFR), which spurs the growth of cancer cells.

Clinical trials:
Tarceva is currently being tested in a wide variety of clinical trials for non-small cell lung cancer, including as first-line treatment; early stage treatment; in combination with chemotherapies; and after surgical removal of lung cancer. Some Tarceva studies are also exploring it as a treatment for small cell lung cancer.

Treatment Overview:
Tarceva is an oral pill, taken daily. For lung cancer patients, the FDA-recommended starting dose is 150 mg each day.

Common side effects:
Targeted therapies tend to have fewer side effects than traditional chemotherapies. The most common side effects for patients receiving Tarceva are rash and diarrhea.

Special warnings:
Some patients taking Tarceva have developed interstitial lung disease (ILD). ILD is a serious and life-threatening lung disease, for more information go to Medline Plus: http://www.nlm.nih.gov/medlineplus/ency/article/000128.htm

The following warnings regarding Tarceva were issued in April, 2009:

  • Gastrointestinal perforation (a hole that goes through the wall of the stomach, small intestine, large bowel, or gallbladder) has been reported in patients receiving Tarceva.

  • In some patients who receive Tarceva, the common side effect of skin rash develops into a more serious and sometimes fatal condition.

  • Serious eye problems, including abnormal eyelash growth, perforation or ulceration (open sore on the surface) of the cornea, and other serous eye disorders have been reported in those using Tarceva.

For more information, please see: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150596.htm

For more information about treatment with Tarceva and side effects:

* for results of the study that lead to FDA approval, see the New England Journal of Medicine http://content.nejm.org/cgi/content/full/353/2/123