FDA Advisory Committee Disapproves Tarceva for First-Line Maintenance Use in Advanced Non-Small Cell Lung Cancer
December 22nd, 2009
OSI Pharmaceuticals, Inc. and Genentech, Inc., a member of the Roche Group, announced 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.