FDAnews
www.fdanews.com/articles/71777-osi-genentech-file-snda-for-tarceva-in-pancreatic-cancer

OSI, Genentech File sNDA for Tarceva in Pancreatic Cancer

May 2, 2005

OSI Pharmaceuticals and Genentech have announced that OSI submitted a supplemental new drug application with the FDA for use of Tarceva plus gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received any previous treatment.

Tarceva (erlotinib) is the first drug to significantly improve survival in a Phase III trial when added to gemcitabine chemotherapy in first-line pancreatic cancer compared to gemcitabine alon, the companies said.