ODAC recommends against approving Tarceva for first-line maintenance use in advanced non-small cell lung cancer
OSI Pharmaceuticals and Genentech announced that FDA ( Food and Drug Administration ) Oncologic Drugs Advisory Committee ( ODAC ) voted 12 to one recommending against approval of 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 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.
Patients 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 ratio, HR=0.71, 29 percent reduction in the risk of cancer progression or death, p