FDA Advisory Committee votes against the approval of Tarceva

Dec 17 2009

OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) and Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG)(OTCQX: RHHBY), announced today that the U.S. 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 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, Ph.D., 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, M.D., 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.

• People who received Tarceva had a 41 percent improvement in the likelihood of living without the disease getting worse (PFS, the primary endpoint) compared to placebo (hazard>
• People whose tumors over-expressed the epidermal growth factor receptor (EGFR) as assessed by Immunohistochemistry (IHC) who received Tarceva had a 45 percent improvement in PFS compared to placebo (the co-primary endpoint; hazard>
• OS, a key secondary endpoint, was also significantly improved by 23 percent with Tarceva compared to placebo (hazard>
• The most commonly reported adverse events in patients who received Tarceva were rash (49 percent) and diarrhea (20 percent). Grade 3 rash and diarrhea were experienced by six percent and two percent of patients, respectively. There were no cases of Grade 4 rash or diarrhea.