TARCEVA APPROVED FOR PANCREATIC CANCER IN EUROPE

OSI Pharmaceuticals and Roche, its international partner for Tarceva (erlotinib), announced that the European Commission has granted marketing authorization for Tarceva in combination with Gemzar (gemcitabine) as first-line therapy for metastatic pancreatic cancer. The combination is the only new treatment regimen in a decade to show, in a Phase III clinical trial, a statistically significant improvement in overall survival compared with gemcitabine alone, when administered as initial therapy to patients with advanced stages of pancreatic cancer.

"We are pleased that Tarceva will be available to pancreatic cancer patients throughout the European Union," Gabriel Leung, president of OSI Oncology, said. "Advanced pancreatic cancer is very difficult to treat and it is an important advance that Tarceva, when combined with gemcitabine, has been shown to produce a statistically significant increase in survival in a cancer where the average life expectancy for a newly diagnosed patient is only about four months."

In November 2005 the FDA approved the use of Tarceva 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 a pivotal study, which demonstrated a 23 percent improvement in overall survival with gemcitabine plus Tarceva versus gemcitabine alone. Tarceva is also approved for this indication in 15 other countries.

Tarceva is a small molecule designed to target the human epidermal growth factor receptor 1 (HER1) pathway, one of the factors critical to cell growth in non-small-cell lung cancer and other solid tumors. Tarceva is designed to inhibit the tyrosine kinase activity of the HER1 signaling pathway inside the cell, which may block tumor cell growth.