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GSK NSCLC Drug Wins Breakthrough Status

FDA recognizes need for dabrafenib treatment

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

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 of dabrafenib administered orally to 25 patients who had NSCLC with the BRAF V600E mutation and who had received at least one previous course of chemotherapy. These interim results were presented at the 2013 American Society for Clinical Oncology Annual Meeting.

Breakthrough Therapy designation includes all the features of the FDA’s Fast Track designation, as well as more intensive guidance from the FDA on a drug’s clinical development program.

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