On April 12, 2016 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that NASDAQ has halted trading of the Company’s common stock (Press release, Clovis Oncology, APR 12, 2016, View Source;p=RssLanding&cat=news&id=2156231 [SID:1234510704]). The U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) is meeting this morning to discuss the company’s New Drug Application (NDA) for rociletinib 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 EGFR T790M mutation.

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About Rociletinib
Rociletinib is the company’s novel, oral, targeted covalent (irreversible) mutant-selective inhibitor of EGFR in development for the treatment of NSCLC in patients with initial activating EGFR mutations, as well as the dominant resistance mutation T790M. Data from both the pivotal, single-arm TIGER-X and TIGER-2 clinical trials served as the basis for the U.S. and EU regulatory submissions for the treatment of advanced mutant EGFR T790M-positive lung cancer. Rociletinib was granted Breakthrough Therapy designation by the FDA in May 2014.