On April 8, 2016 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that the U.S. Food and Drug Administration (FDA) posted briefing materials in advance of the Oncologic 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 (Press release, Clovis Oncology, APR 8, 2016, View Source [SID:1234510568]). Schedule your 30 min Free 1stOncology Demo! About T790M-Positive Mutant EGFR NSCLC Know more, wherever you are: Approximately 10-15 percent of patients with NSCLC in the United States have the EGFR mutation. While the majority of these patients will respond to treatment with first- or second-generation EGFR-targeted tyrosine kinase inhibitors (TKIs), most patients will eventually develop acquired resistance to these therapies, predominantly due to the primary resistance mutation, T790M.
The ODAC meeting is scheduled to take place on April 12, 2016 from 8:30 a.m. ET to 1 p.m. ET. Briefing materials and webcast information can be found on the FDA website at View Source
The FDA has set a target action date of June 28, 2016 for rociletinib under the Prescription Drug User Fee Act (PDUFA).
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Lung cancer is the second most common cancer in the United States, with more than 200,000 new cases each year, and is the leading cause of cancer-related death. NSCLC accounts for almost 85 percent of lung cancers, and the five-year survival rate in locally advanced and metastatic patients is 27 and four percent, respectively.
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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.