Tarceva is the first drug in a Phase III trial to have shown a significant improvement in overall survival when added to gemcitabine chemotherapy as initial treatment for pancreatic cancer.

Tarceva is a once-daily oral tablet already approved for use in patients with non-small cell lung cancer whose disease has progressed after one or more courses of chemotherapy.

Roche, OSI's international partner for Tarceva, has submitted a Marketing Authorization Application (MAA) to the European Health Authorities for Tarceva for the treatment of pancreatic cancer.

"Improvements in therapy in advanced pancreatic cancer have been very difficult to come by," says study chair Dr. Malcolm Moore, "Erlotinib represents a notable step forward for patients and healthcare providers in a disease with a very poor prognosis." Dr. Moore is a medical oncologist at Princess Margaret Hospital in Toronto and Chair of the Gastrointestinal Disease Site, National Cancer Institute of Canada Clinical Trials Group.

Fourth Leading Cause of Cancer Deaths

Pancreatic cancer has the highest one-year mortality rate of any cancer. The average life expectancy for a patient diagnosed with metastatic pancreatic cancer is three to six months, according to the Pancreatic Cancer Action Network (PanCAN), a national patient advocacy organization for the pancreatic cancer community.

More than 216,000 people worldwide are diagnosed each year with pancreatic cancer, according to the World Health Organization. About 32,180 people in the United States will be diagnosed with pancreatic cancer in 2005, and about 31,800 will die of the disease, the American Cancer Society predicts.

Although pancreatic cancer accounts for just 2 percent of new cancer cases in the United States, it is the fourth leading cause of all cancer deaths.

"We welcome the approval of Tarceva as part of a combination therapy with gemcitabine for pancreatic cancer patients," says Julie Fleshman, president and CEO of PanCAN. "The disease is incredibly deadly with most patients not surviving past one year. For years, treatments for pancreatic cancer have lagged behind other cancers, so the availability of Tarceva means patients now have more treatment options as they make informed decisions."

Significant Improvement in Progression-Free Survival

The FDA based its approval decision on results from a randomized double-blind, placebo-controlled Phase III clinical study of Tarceva in combination with gemcitabine chemotherapy in patients with unresectable locally advanced or metastatic pancreatic cancer.

The study met its primary endpoint of improving overall survival. Compared to gemcitabine plus placebo, those patients receiving gemcitabine plus Tarceva 100 mg/day demonstrated a statistically significant (23 percent) improvement in overall survival. After one year, 24 percent of patients receiving Tarceva plus gemcitabine were alive compared to 19 percent of patients receiving gemcitabine plus placebo.

A statistically significant improvement in progression-free survival also was demonstrated. Although no difference in tumor response was observed, the disease control rate was significantly improved (59 percent in patients receiving Tarceva plus gemcitabine versus 49 percent in the gemcitabine plus placebo arm).

The global study was conducted by the National Cancer Institute of Canada in collaboration with OSI Pharmaceuticals.