Clovis Oncology has announced that the US Food and Drug Administration has granted breakthrough therapy status to the company for its lung cancer compound.
According to Clovis, the US FDA has granted the status to CO-1686, a drug designed for the treatment of non-small cell lung cancer. CO-1686 is targeted therapy: an oral epidermal growth factor receptor (EGFR) and covalent inhibitor that is currently in Phase II development. It is being tested for the treatment of patients with non-small cell lung cancer (NSCLC) who are found to carry initial activating EGFR mutations as well as the T790M dominant resistance mutation.
"This designation is well timed for us," said Clovis Chief Executive Patrick Mahaffy. "The increased interaction with FDA that it provides will come as we are initiating our registration studies and preparing to submit out initial new drug application by mid-2015."
Clovis will present extended data on CO-1686 at the upcoming annual meeting of the American Society of Clinical Oncology.
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