FDA Advisory Committee Recommends Against Approving Tarceva for First-Line Maintenance Use in Advanced Non-Small Cell Lung Cancer

OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) and Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG)(OTCQX: RHHBY), 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. 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...

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