Celebrating Today’s Accomplishments and Tomorrow’s Possibilities

Currently, lung cancer is the leading cause of cancer deaths in the United States.¹ Pancreatic cancer is the fourth-leading cause of cancer deaths.¹ Tarceva has shown a survival benefit with generally manageable common side effects in both of these complex diseases.

Since it came on the US market 5 years ago, Tarceva has had many "firsts," which have led to its widespread and continued use.

Some patients have reported serious side effects with Tarceva. Talk to your doctor about any side effects you may have.

Tarceva is the first treatment of its kind that has been shown to help some patients with NSCLC live longer after chemotherapy has failed.²
- In a large clinical study (n=731), 31.2% of patients taking Tarceva were alive one year after starting therapy, compared with 21.5% of patients taking a sugar pill.²
- In this same clinical study, median overall survival for patients taking Tarceva was 6.7 months, compared with 4.7 months for patients taking a sugar pill.²
Tarceva is the first treatment of its kind that has been shown to delay the growth of cancer and, in some cases, shrink tumors in some patients with NSCLC after chemotherapy has failed.³
- In a large clinical study (n=638), Tarceva was shown to slow or stop the growth of cancer and/or shrink tumors in 44.0% of patients, compared with 27.5% of patients taking a sugar pill.³
Tarceva is the first treatment of its kind that, when taken with chemotherapy, has been shown to improve one-year and overall survival in some patients with pancreatic cancer.²
- In a large clinical study (n=521), 23.8% of patients taking Tarceva plus gemcitabine were alive one year after starting therapy, compared with 19.4% of patients receiving gemcitabine alone.²
- In this same clinical study, median overall survival for patients taking Tarceva plus gemcitabine was 6.4 months, compared with 6.0 months for patients receiving gemcitabine alone.²
Tarceva is the first treatment of its kind that has been shown to improve median survival—or the time when half the patients are expected to be alive—in several types of patients with NSCLC after chemotherapy has failed. An analysis of patient histories as they related to data from a clinical study showed that Tarceva³:
- More than doubled median survival compared with sugar pill in patients with PS 0/1, squamous-cell histology (10.0 months compared with 4.2 months).³
- Tripled median survival compared with sugar pill in female patients with adenocarcinoma (11.75 months compared with 3.91 months).³
- Tripled median survival compared with sugar pill in never smokers (13.37 months compared with 4.32 months).³
Genentech and OSI Pharmaceuticals are committed to the continued research that will lead to more firsts in changing the way NSCLC and pancreatic cancer are treated.

Indications and Usage for Advanced Non-Small Cell Lung Cancer Patients

Tarceva is prescribed for patients with advanced-stage non-small cell lung cancer (NSCLC) whose cancer has not spread or grown after initial treatment with certain types of chemotherapy (maintenance treatment).

Tarceva is prescribed for patients with advanced-stage non-small cell lung cancer (NSCLC) whose cancer has spread or grown after receiving at least 1 chemotherapy regimen (second/third-line treatment).

Tarceva is not meant to be used at the same time as certain types of chemotherapy for NSCLC.

Important Safety Information

Possible effects on the lungs

There have been reports of serious adverse events involving the lungs in a small number of patients taking Tarceva. These events have included death in some patients. The medical name for these types of events is interstitial (in-tur STISH-ul) lung disease-like events (or ILD-like events).

Possible effects on the kidneys and liver

Liver and/or kidney problems (including deaths) have been reported in some patients taking Tarceva. Let your healthcare provider (HCP) know if you have a history of liver or kidney disease.

Possible effects on the stomach and intestines

Some patients taking Tarceva have developed a hole in the lining of their stomach or intestines (including deaths).

Possible effects on the skin

Some patients taking Tarceva have developed serious skin conditions. Some patients have died from these conditions.

Possible effects on the eye

Some patients taking Tarceva have developed eye irritation and damage to the cornea. Patients should tell their HCP about eye problems that get worse, including eye pain.

Tarceva and pregnancy and breast-feeding

Women should not become pregnant while on treatment with Tarceva. DO NOT breast-feed while receiving treatment with Tarceva.

When to call your HCP

Call your HCP right away if you 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

Before you start taking Tarceva

Some patients taking Tarceva have experienced difficulty with blood clotting, and bleeding events, including gastrointestinal and non-gastrointestinal bleeding. Patients taking blood thinners (Coumadin®, warfarin or other coumarin-derivatives) should be monitored regularly.

Taking other medicines and herbal supplements with Tarceva

It is important that you tell your HCP about all of the medicines and herbal supplements you are taking. DO NOT start taking any new medicines or herbal supplements before talking with your HCP. Tarceva may also affect other medications you are taking.

DO NOT eat grapefruit or drink grapefruit juice while on treatment with Tarceva, except under the care of your HCP.

Smoking

Smoking may affect how well Tarceva works for you. If you smoke, you should stop smoking before starting treatment with Tarceva. Talk with your HCP about how to quit smoking. If you continue to smoke, you should talk to your HCP before taking Tarceva.

Common side effects of Tarceva

The most common side effects in patients who took Tarceva were mild to moderate rash and diarrhea. You may also have other changes in your skin.

Hair and nail changes have been seen with Tarceva.

Always let your HCP know if you have any side effects, and ask about the best way to handle them.

Tarceva is not right for everyone. Ask your HCP if once-daily Tarceva is right for you.

Please see the Tarceva full prescribing information for complete safety information.

References:

1. American Cancer Society. Cancer Facts & Figures 2009. Atlanta, GA: American Cancer Society; 2009.
2. Tarceva [package insert]. Melville, NY: OSI Pharmaceuticals Inc; 2009.
3. Data on file, OSI Pharmaceuticals Inc.