On Monday, Clovis Oncology (CLVS) said that federal regulators had given its experimental lung cancer drug Breakthrough Therapy designation. The news sent CLVS stock up more than 4% in Tuesday morning trading.
CLVS indicated that the U.S. Food and Drug Aministration (FDA) had granted the designation to its “investigational agent CO-1686 as monotherapy for the treatment of second-line EGFR mutant NSCLC in patients with the T790M mutation” based on the interim results from an on-going Phase 1/2 study of the drug.
CO-1686 is described as an “oral, targeted covalent inhibitor of mutant forms of the epidermal growth factor receptor (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.”
CLVS President and CEO Patrick J. Mahaffy, President noted that Breakthrough Therapy status for CO-1686 comes at a good moment for CLVS. “This designation is well timed for us as well, as the increased interaction with FDA that it provides will come as we are initiating our registration studies and preparing to submit our initial New Drug Application (NDA) by mid-2015,” he said in a statement.
Clovis Oncology will provide additional information regarding the results of its clinical study of CO-1686 at the 2014 American Society of Clinical Oncology Annual Meeting on May 31.
On Monday, CLVS stock closed at $56.77 per share.
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