GlaxoSmithKline has received Breakthrough Therapy designation from the FDA for Tafinlar (dabrafenib) for treatment of patients with metastatic BRAF V600E mutation-positive non-small cell lung cancer (NSCLC) who have received at least one prior line of platinum-containing chemotherapy. Dabrafenib is not approved or licensed anywhere in the world for use in this treatment setting. The Breakthrough Therapy designation was based on interim efficacy and safety results from an ongoing Phase II study ...