“This study is important because it shows the benefit of a new approach to treat this deadly disease,” said Dr Malcolm Moore, chief of Medical Oncology and Hematology at Princess Margaret Hospital, University of Toronto.
In November 2005, the FDA approved the use of Tarceva in 100mg strength in combination with gemcitabine for the first-line treatment of patients with pancreatic cancer in patients who have not received previous chemotherapy. The approval was based on this phase III study, which demonstrated a 23% 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.