The Oncologic Drugs Advisory Committee (ODAC) panel will review at its September 13, 2005 meeting the use of Tarceva (erlotinib) plus gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received any previous treatment, OSI Pharmaceuticals, Inc. announced here. The ODAC panel is a committee of external experts, formed by the US FDA, to advise the FDA in the evaluation of marketed and investigational drugs for use in the treatment of cancer.

In July 2005, the FDA accepted for filing and review the supplemental New Drug Application (sNDA) for use of Tarceva plus gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received previous chemotherapy and had assigned Tarceva priority review status. Based on this priority review status, the FDA has six months from receipt of the sNDA data, or until November 2, 2005, to take action on the sNDA filing. Tarceva is the only agent shown to provide a statistically significant survival benefit in patients treated in first-line locally advanced or metastatic pancreatic cancer in combination with gemcitabine chemotherapy, the company release said.

Tarceva was approved by the FDA in November 2004 and is an oral tablet indicated for daily administration for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.