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FDA Posts Briefing Documents for Advisory Committee Meeting to Review Clovis Oncology’s Rociletinib for Treatment of Advanced T790M-Positive Mutant Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer

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Additional Relevant Details The FDA posted briefing materials in advance of theOncologic Drugs Advisory Committee (ODAC) meeting to discuss accelerated approval of the New Drug Application (NDA) for rociletinib, an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the T790M mutation.
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Occurred on:
Apr 08, 2016
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Related Keywords Adcom, Rociletinib, T790m-positive Mutant Nsclc