Tarceva® (erlotinib)
Tarceva in Advanced Non-Small Cell Lung and Advanced Pancreatic Cancers Tarceva® (erlotinib), a daily pill, is one of the first targeted treatments approved by the U.S. Food and Drug Administration (FDA) designed to block tumor cell growth by targeting the human epidermal growth factor receptor (EGFR/HER1).
In November 2004, the FDA approved Tarceva for use in people with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease had progressed after initial chemotherapy (second- or third-line treatment). In November 2005, Tarceva used with chemotherapy (gemcitabine) was approved as first-line treatment in people with advanced pancreatic cancer, who had not received prior chemotherapy.1 The National Comprehensive Cancer Network (NCCN), an alliance of 21 of the world's leading cancer centers, recommends Tarceva as a second-line and third-line treatment for people with advanced NSCLC, when given after one or more ineffective chemotherapies.2 The NCCN recommends Tarceva as a first-line treatment for people with advanced pancreatic cancer, when given with chemotherapy.2
Lung cancer is the leading cause of cancer deaths in the United States and pancreatic cancer is the fourth leading cause of cancer deaths.3
Tarceva "Firsts" in Advanced Non-Small Cell Lung and Pancreatic Cancers
- Tarceva was the first FDA-approved medicine in more than a decade that may help people with advanced pancreatic cancer live longer, when given with chemotherapy (median survival: 6.4 months vs. 6.0 months; hazard ratio of 0.81; p=0.028)
- Tarceva was the first FDA-approved medicine that may help people with advanced NSCLC, including those with non-squamous and squamous cell histologies, who have progressed after initial chemotherapy, live longer (median survival: 6.7 months vs. 4.7 months; hazard ratio 0.73; p<0.001).
Tarceva Clinical Study in Non-Small Cell Lung Cancer
- In the Phase III study (BR.21), some patients with advanced NSCLC cancer who received Tarceva lived longer, when given after one or more prior chemotherapies, compared to patients who received placebo (sugar pill)1
- Thirty-one percent of patients treated with Tarceva survived at least one year compared to 21.5% with placebo
- Some patients treated with Tarceva lived two months longer (median overall survival: 6.7 months vs. 4.7 months)
- Some patients treated with Tarceva lived two weeks longer without their disease worsening (median progression-free survival: 9.9 weeks vs. 7.9 weeks)
- Results from two, placebo-controlled Phase III trials in patients with advanced NSCLC showed no clinical benefit in first-line treatment with Tarceva plus platinum-based chemotherapy, and its use is not recommended in that setting1
Some rare, but possibly serious, side effects may occur with Tarceva. In large clinical studies, there were infrequent reports of a lung injury known as Interstitial Lung Disease (ILD) and have included fatalities. Tarceva may cause liver problems. Women should also avoid becoming pregnant or breastfeeding while taking Tarceva.
Rash and diarrhea were the most common side effects associated with Tarceva. They were generally mild to moderate. In large clinical studies, severe rash occurred in 9% of patients and severe diarrhea occurred in 6% of patients. Patients may also have other changes in their skin. Hair and nail changes have been seen with Tarceva.
Tarceva Clinical Study in Pancreatic Cancer
- In the Phase III study (PA.3), some patients with advanced pancreatic cancer who received Tarceva plus chemotherapy, compared to chemotherapy alone, lived longer1
- Twenty-four percent of people treated with Tarceva survived at least one year
- Some patients treated with Tarceva and chemotherapy lived two weeks longer (overall survival: 6.4 months vs. 6.0 months)
Fatigue, rash, nausea, loss of appetite, and diarrhea were the most common side effects associated with Tarceva plus gemcitabine therapy in a large clinical study.
Tarceva Indications Second-line advanced NSCLC Tarceva is FDA-approved for use as a monotherapy in patients with locally advanced or metastatic NSCLC whose disease has progressed after one or more courses of chemotherapy.
Results from two multicenter, placebo-controlled, randomized, Phase III trials conducted in first-line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of Tarceva with platinum-based chemotherapy, and its use is not recommended in that setting.
First-line advanced pancreatic cancer Tarceva in combination with gemcitabine is indicated for first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
Tarceva Important Safety Information In clinical studies, there were infrequent reports of lung injuries similar to Interstitial Lung Disease (ILD)-like events in patients taking Tarceva for the treatment of non-small cell lung cancer (NSCLC) or other advanced solid tumors. Reports of these ILD-like lung injuries have been serious and have included deaths in some patients.
Liver and/or kidney problems (including deaths) have been reported in some patients taking Tarceva.
Holes that formed in the stomach, small intestine, or large bowel (including deaths) have been reported in patients taking Tarceva.
Severe blistering skin reactions including cases similar to Stevens-Johnson syndrome (including deaths) have been reported in patients taking Tarceva.
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. Patients should tell their doctor about eye problems, including eye pain that gets worse.
Tarceva may cause harm to an unborn baby or may cause possible risk of pregnancy loss. 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.
Patients who smoke should stop smoking while taking Tarceva, as it may affect how well Tarceva works for them. If patients continue to smoke they should speak to their doctor before taking Tarceva.
Patients should let their doctor know if they are taking other prescription or over-the-counter drugs or herbal supplements before they start taking Tarceva, and should not start taking any new drugs or herbal supplements before talking to their doctor. Patients should not eat grapefruit or drink grapefruit juice while taking Tarceva. Tarceva may also affect other medications patients are taking.
Rash and diarrhea were the most common side effects associated with Tarceva in the NSCLC clinical study. Patients may also have other changes in their skin.
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.
For full prescribing information, please call 1-877-TARCEVA or visit http://www.tarceva.com.
How Tarceva Works (Proposed Mechanism Of Action)
- EGFR/HER1 is one of four receptors in the human epidermal growth factor signaling pathway, which has been shown to have a significant impact on cancer cells' ability to grow, spread in the body (metastasize) and survive5,6
Tarceva is co-developed in the United States by Genentech, Inc., a wholly owned member of the Roche Group, and OSI Pharmaceuticals, Inc., and is a trademark of OSI Pharmaceuticals, Inc., Melville, NY 11747, USA.
References
1 Tarceva [package insert]. Melville, NY: OSI Pharmaceuticals, Inc.; 2009.
2 National Comprehensive Cancer Network, Inc. Clinical Practice Guidelines in Oncology; Version 1.2009.
3 American Cancer Society. Cancer Facts & Figures 2008.
http://www.cancer.org/downloads/STT/2008CAFFfinalsecured.pdf
4 Carter P, Presta L, Gorman CM, et al. Humanization Of An Anti-p185HER2 Antibody For Human Cancer Therapy. ProcNatl Acad Sci. 1992;89:4285-4289.
5 Prenzel N, Fischer OM, Streit S, Hart S, Ullrich A. The Epidermal Growth Factor Receptor Family As A Central Element For Cellular Signal Transduction And Diversification. Endocrine-Related Cancer. 2001;8:11-31.
6 Britten CD. Targeting ErbB Receptor Signaling: A Pan-ErbB Approach To Cancer. Mol Cancer Ther. 2004;3:1335-1342.