OSI Pharmaceuticals has submitted a supplemental New Drug Application (sNDA) with the US FDA for use of Tarceva (erlotinib) plus gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received any previous treatment. Tarceva 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 alone.

"There is an urgent need for additional therapeutic options for patients with advanced pancreatic cancer and we look forward to working closely with the FDA through this review process," stated Colin Goddard, CEO of OSI Pharmaceuticals.

"Pancreatic cancer is difficult to treat and is a disease in which only 20 percent of patients survive one year after diagnosis. The improved survival observed in the Phase III trial that is the basis for this filing represents a potential treatment advance for both patients and physicians," said Hal Barron, Genentech's senior vice president of Development and chief medical officer.

The sNDA filing is based on a pivotal Phase III multi-centre, randomized, double-blind, placebo-controlled trial evaluating Tarceva in patients with locally advanced or metastatic pancreatic cancer. Results of the trial were presented in January at the Second Annual Gastrointestinal Cancers Symposium in Hollywood, Fla. A total of 569 patients were randomized in the study, to receive Tarceva plus gemcitabine or gemcitabine plus placebo.

Tarceva is currently approved by the FDA as a monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen and is an oral tablet indicated for daily administration. Results from two earlier large, randomized, placebo-controlled clinical trials in first-line advanced NSCLC patients showed no clinical benefit with concurrent administration of Tarceva with doublet platinum-based chemotherapy (carboplatin and paclitaxel or gemcitabine and cisplatin) and its use is not recommended in that setting.

According to the World Health Organization, more than 216,000 people worldwide are diagnosed each year with pancreatic cancer. The American Cancer Society estimates that in 2005 approximately 32,180 people in the United States will be diagnosed with pancreatic cancer and approximately 31,800 will die of the disease.