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Roche / Tarceva
Tarceva is a small molecule human epidermal growth factor type 1/epidermal growth factor receptor (HER1/EGFR) inhibitor which has demonstrated, in a Phase III clinical trial, an increased survival in advanced non-small cell lung cancer (NSCLC) patients. In a Phase III trial, Tarceva has also shown an improvement in overall survival when added to gemcitabine chemotherapy as initial treatment for pancreatic cancer.
Status
In November 2004, the U.S. Food and Drug Administration (FDA) approved Tarceva for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Tarceva was approved under the FDA's Pilot Program for Continuous Marketing Applications, a program designed for investigational products, such as Tarceva, that have been given Fast Track status and that have demonstrated significant promise in clinical trials as a therapeutic advance over available therapy for a disease or condition.
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