Dabrafenib Receives FDA Breakthrough Therapy Designation for BRAF-Mutated NSCLC


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The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for dabrafenib (Tafinlar) for the 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.

The Breakthrough Therapy designation was based on interim efficacy and safety results from an ongoing phase II study of dabrafenib in 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 ASCO Annual Meeting. ■



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