Tarceva^® (erlotinib), a once-a-day pill, was one of the first targeted treatments approved by the U.S. Food and Drug Administration (FDA) specifically designed to target the epidermal growth factor receptor (EGFR) pathway. Tarceva has been shown to help some people with advanced NSCLC and advanced pancreatic cancer live longer.

Tarceva in Advanced Non-Small Cell Lung Cancer
Tarceva is approved for use in people with advanced NSCLC in two settings:

• As a treatment for people whose lung cancer has not worsened following initial treatment with chemotherapy (maintenance therapy).
• As a treatment for people whose lung cancer has worsened after receiving one or more courses of chemotherapy (second- or third-line therapy).

Tarceva is not intended to be used at the same time as chemotherapy for advanced NSCLC.

Tarceva in Advanced Pancreatic Cancer
Tarceva, used with gemcitabine chemotherapy, is also FDA-approved for treating people with advanced pancreatic cancer who had not received prior chemotherapy (first-line treatment). Tarceva was the first FDA-approved medicine in more than a decade for advanced pancreatic cancer and is the only targeted therapy approved for this devastating disease with few treatment options.

OSI, together with our partners Genentech and Roche, continues to invest in the future development of Tarceva. Our longer-term strategy for Tarceva is to evaluate its efficacy and safety in the front-line and adjuvant settings in NSCLC, other cancers, and in combination with other targeted therapies.

For more information on Tarceva clinical trials, please go to www.clinicaltrials.gov*.

Proposed Mechanism of Action

Tarceva is designed to inhibit signaling of the epidermal growth factor receptor (EGFR) pathway. Tarceva works inside the tumor cell by inhibiting the tyrosine kinase activity of the EGFR pathway, which is one of the critical growth factors in NSCLC and pancreatic cancer.

By blocking this activity, it is thought that Tarceva may help slow or stop the growth of tumors. The way Tarceva works to treat cancer is not fully known.

Safety Information

There have been infrequent reports of serious Interstitial Lung Disease (ILD)-like events including deaths in patients taking Tarceva. Serious side effects (including deaths) in patients taking Tarceva include liver and/or kidney problems; gastrointestinal (GI) perforations (the development of a hole in the stomach, small intestine, or large intestine); and severe blistering skin reactions including cases similar to Stevens-Johnson syndrome. Patients taking Tarceva plus gemcitabine were more likely to experience bleeding and clotting problems such as heart attack or stroke. Eye irritation and damage to the cornea have been reported in patients taking Tarceva. Women should avoid becoming pregnant and avoid breastfeeding while taking Tarceva. Patients should call their doctor right away if they have these signs or symptoms: new or worsening skin rash; serious or ongoing diarrhea, nausea, loss of appetite, vomiting or stomach pain; new or worsening shortness of breath or cough; fever; eye irritation. Rash and diarrhea were the most common side effects associated with Tarceva in the NSCLC clinical studies. Fatigue, rash, nausea, loss of appetite and diarrhea were the most common side effects associated with Tarceva plus gemcitabine therapy in the pancreatic cancer clinical study.

View full prescribing information for additional safety information.

Non-Small Cell Lung Cancer

According to the American Cancer Society, lung cancer is the leading cause of cancer death in the United States and approximately 159,000 Americans died from the disease in 2009. NSCLC is the most common type of lung cancer. Most people are diagnosed with advanced stage disease and only one to five percent of people with advanced stage (IIIB/IV) NSCLC survive five years.

Pancreatic Cancer

Pancreatic cancer is the fourth leading cause of cancer deaths in the United States. In 2009, the American Cancer Society estimated that more than 42,000 people were diagnosed and about 35,000 people died from the disease. Pancreatic cancer tends to spread quickly in the body, leading to high mortality and short life expectancy.

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