Roche, Genentech and OSI Pharmaceuticals yesterday said they are seeking US approval of their blockbuster anticancer agent, Tarceva (erlotinib), for a new indication – the first line treatment of patients with advanced pancreatic cancer.
Tarceva received its first approval last November for the treatment of non-small cell lung cancer [[22/11/04d]] and looks set to become a big-selling drug for the firms. This latest filing includes data from a 570-patient Phase III study showing Tarceva prolonged survival 24% when added to Eli Lilly’s Gemzar (gemcitabine) in patients with previously untreated advanced pancreatic cancer. Results showed 24% of patients given the dual therapy were alive one year later, versus 17% of those given Gemzar alone.
“We are confident that the clear survival benefit demonstrated by Tarceva in pancreatic and lung cancer patients reinforces the potential of this medicine in other cancer types. We look forward to discussing and filing this data with the EU regulatory authorities.” Pancreatic cancer is the fourth leading cause of all cancer deaths worldwide and is the tenth most frequently occurring cancer in Europe.