FDA Grants Drug Breakthrough Therapy Designation for NSCLC

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FDA Grants Drug Breakthrough Therapy Designation for NSCLC
FDA Grants Drug Breakthrough Therapy Designation for NSCLC

Clovis Oncology announced that the FDA has granted Breakthrough Therapy designation to CO-1686 as monotherapy for the treatment of second-line epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) in patients with the T790M mutation. CO-1686 is a novel, oral, targeted irreversible inhibitor of mutant forms of the 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.

The designation was based on interim efficacy and safety results from an ongoing Phase 1/2 study of CO-1686. An objective response rate of 64% in 14 of 22 evaluable T790M positive patients was observed. There was no evidence of systemic wild-type EGFR inhibition.

RELATED: Lung Cancer Resource Center

Currently Clovis Oncology is enrolling patients for two Phase 2 expansion cohorts of its Phase 1/2 study in EGFR mutant patients with the T790M mutation. Data from the expansion cohorts, combined with data from the TIGER2 study, in T790M positive patients directly after progression on their first and only TKI therapy, are expected to serve as the basis of an NDA submission for CO-1686 by mid-2015.

For more information visit ClovisOncology.com.

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