Description Tarceva® (erlotinib) is a small molecule designed to target the human epidermal growth factor receptor (HER1) pathway, also known as epidermal growth factor receptor (EGFR), which is critical to cell growth in many cancers. HER1/EGFR is a key component of the HER signaling pathway, which can be involved in the formation and growth of numerous cancers.

Development Status Tarceva is being evaluated in Phase III clinical trials for first-line and second-line metastatic non-small cell lung cancer, for adjuvant non-small cell lung cancer, and Tarceva is being evaluated in combination with Avastin for first-line and second-line metastatic non-small cell lung cancer.

Tarceva is being developed in collaboration with F. Hoffmann-La Roche and OSI Pharmaceuticals, Inc.

Approved Uses

• In November 2004, the U.S. Food and Drug Administration (FDA) approved Tarceva for the treatment of patients as monotherapy with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
• In November 2005, the FDA approved Tarceva in combination with gemcitabine chemotherapy for the first-line treatment of patients with locally advanced, inoperable or metastatic pancreatic cancer.

Read more about Tarceva's approved uses.

Additional Information on Clinical Trials For inquiries about our clinical trials, please submit a request through our information request form or call (888) 662-6728.

National Institutes of Health Website: www.clinicaltrials.gov

January 2008