The FDA Oncologic Drugs Advisory Committee (ODAC) has voted 12 to one recommending against approval of the first-line maintenance use of erlotinib (Tarceva®) in patients 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 expected to make a final decision by January 18, 2010. The ODAC recommendation was based on a review of data from the pivotal phase III SATURN study.

An application to the EMEA for use in this setting was submitted in March 2009, and currently, erlotiniob is licensed for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.