OSI Pharmaceuticals, Inc has announced that results published in the Journal of Clinical Oncology show that adding Tarceva (erlotinib) to gemcitabine chemotherapy significantly improves survival when administered as first-line therapy to patients with advanced pancreatic cancer. Data from this study, conducted by the National Cancer Institute of Canada (NCIC), formed the basis of both the US and European approvals for Tarceva in this patient population.
"This study is important because it shows the benefit of a new approach to treat this deadly disease," said Dr Malcolm Moore, Study chair and chief of medical oncology and Haematology at Princess Margaret Hospital, University of Toronto. "This is the first study in ten years to demonstrate an improvement in survival in pancreatic cancer, and as a physician I'm delighted to have additional treatment options for my patients."
In November 2005, the US Food and Drug Administration (FDA) approved the use of Tarceva (100 mg) in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer in patients who have not received previous chemotherapy.
The approval was based on this pivotal phase III study, which demonstrated a 23 per cent improvement in overall survival with gemcitabine plus Tarceva versus gemcitabine alone. In January 2007, the European Commission granted marketing authorization for Tarceva in combination with gemcitabine for the treatment of metastatic pancreatic cancer. This indication for Tarceva is also approved in 15 other countries worldwide.