OSI Pharmaceuticals and Genentech, a wholly owned member of the Roche Group have reported that the 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 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, said the company.
The company claims that 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.
According to the company, people who received Tarceva had a 41% improvement in the likelihood of living without the disease getting worse (PFS, the primary endpoint) compared to placebo.
People whose tumors over-expressed the epidermal growth factor receptor (EGFR) as assessed by Immunohistochemistry (IHC) who received Tarceva had a 45 % improvement in PFS compared to placebo. OS, a key secondary endpoint, was also improved by 23 % with Tarceva compared to placebo, said the company.
Colin Goddard, chief executive officer of OSI Pharmaceuticals, said: “We are disappointed with the Committee’s recommendation and will work diligently to respond to the issues that arose today as quickly as possible.”