CO-1686 was assigned breakthrough designation by the FDA as monotherapy for the treatment of EGFR-mutant NSCLC patients.
Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (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 (irreversible) 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.
“We very much appreciate this designation by FDA, which recognizes the meaningful benefit CO-1686 may provide patients with T790M positive NSCLC,” said Patrick J. Mahaffy, President andCEO of Clovis Oncology. “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.”
Read the release here: http://bit.ly/1ncuygp
Source: The Street