GSK Granted Breakthrough Therapy Designation for Cancer Drug

Jan 13, 2014


The FDA has granted Breakthrough Therapy designation for GlaxoSmithKline's Tafinlar (dabrafenib) for treatment of patients with lung cancer.

Tafinlar, already approved for melanoma, was designated an FDA breakthrough therapy on Monday for 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.

Enacted as part of the 2012 FDA Safety and Innovation Act, the Breakthrough Therapy designation is intended to expedite development and review of drugs to treat serious or life-threatening medical conditions when preliminary clinical evidence demonstrates that the drug may have substantial improvement on at least one clinically significant endpoint over available therapies.