“Clovis Oncology, Inc. 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.”
Editor’s note: CO-1686 is a targeted therapy drug that is meant to treat patients whose tumors have mutations in the EGFR gene, as detected by molecular testing. Some tumors with EGFR mutations become resistant to first-line treatment and develop a new mutation called T790M. Evidence shows that non-small cell lung cancer (NSCLC) patients with T790M may benefit from second-line treatment with CO-1686.The drug has received a Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA). This means that the FDA finds CO-1686 to be very promising compared to currently available treatments for T790M-mutated NSCLC, and will accelerate the approval process that would ultimately permit oncologists to prescribe the drug outside of a clinical trial.