Clovis drug gets BTD tag

The FDA designates Clovis Oncology's (CLVS +1.4%) anti-EGFR drug CO-1686 a Breakthrough Therapy for the treatment of second-line EGFR mutant non-small cell lung cancer in patients with the T790M mutation.

Clovis plans to submit its NDA by mid-2015 based on data from two expansion cohorts of its Phase 1/2 study in EGFR mutant patients with the T790M mutation and from the Tiger2 study which evaluates the drug in T790M-positive patients directly after progression on their first and only TKI therapy.

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