OSI Pharmaceuticals, Inc and Genentech, Inc, a wholly-owned member of the Roche Group, announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to one recommending against approval of the daily pill Tarceva (erlotinib) for first-line maintenance use in people with advanced or metastatic non-small cell lung cancer (NSCLC) whose cancer has not progressed (grown or spread) following first-line treatment with platinum-based chemotherapy. The US FDA is not bound by the recommendations of its advisory committees and the agency is expected to make a decision whether to approve Tarceva for this use by January 18, 2010.

"We are disappointed with the committee's recommendation and will work diligently to respond to the issues that arose today as quickly as possible," said Colin Goddard, chief executive officer of OSI Pharmaceuticals. "We continue to believe that having an oral, well-tolerated treatment option that can maintain the initial benefit from cytotoxic chemotherapy would be an important advance in treating advanced lung cancer and will explore further with regulatory agencies how best to pursue this outcome."

"We continue to hope Tarceva may be an option that could help more people with advanced non-small cell lung cancer live longer without the disease getting worse," said Hal Barron, executive vice president, Global Development and chief medical officer, Genentech. "We will work closely with OSI to carefully review and address the Committee's comments."

The ODAC recommendation was based on a review of data from the pivotal phase-III Saturn study which showed a statistically significant improvement in both progression-free survival (PFS) and overall survival (OS) with Tarceva compared to placebo in the NSCLC maintenance setting. There were no new or unexpected safety signals in the study and adverse events were consistent with those previously reported for Tarceva in NSCLC.

SATURN was an international, placebo-controlled, randomized, double-blind, Phase III study that enrolled 889 patients with advanced NSCLC at approximately 160 sites worldwide.

Tarceva is a once-a-day pill that targets the EGFR pathway. Tarceva is designed to inhibit the tyrosine kinase activity of the EGFR signaling pathway inside the cancer cell, one of the critical growth factors in NSCLC and pancreatic cancer.

OSI Pharmaceuticals is committed to "shaping medicine and changing lives" by discovering, developing and commercializing high-quality, novel and differentiated targeted medicines designed to extend life and improve the quality of life for patients with cancer and diabetes/obesity.