Clovis Oncology, Inc. CLVS announced today that it has
submitted its New Drug Application (NDA) regulatory filing to the U.S.
Food and Drug Administration (FDA) 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 as detected by an
FDA approved test. 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. Rociletinib was granted Breakthrough Therapy designation by the
U.S. FDA in May 2014.
See full press release
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