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May 19, 2014
16:02 EDTCLVSClovis receives breakthrough therapy designation for CO-1686
Clovis Oncology announced that the FDA has granted Breakthrough Therapy designation for the company’s investigational agent CO-1686 as monotherapy for the treatment of second-line EGFR mutant NSCLC in patients with the T790M mutation. The Breakthrough Therapy designation was granted based on interim efficacy and safety results from an ongoing Phase 1/2 study of CO-1686. CO-1686 is the Company’s novel, oral, targeted covalent inhibitor of mutant forms of the epidermal growth factor receptor, or EGFR, for the treatment of non-small cell lung cancer in patients with initial activating EGFR mutations as well as the dominant resistance mutation T790M.
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