Tag Archives: dabrafenib

Novartis announces EC approval for Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) for adjuvant treatment of BRAF V600 mutation-positive melanoma

Approval based on COMBI-AD study demonstrating greater than 50% reduction in risk of disease recurrence or death in stage III melanoma patients   More than 50% of stage III melanoma patients are likely to recur to stage IV during their lifetime … Read the full press release

GlaxoSmithKline plc received FDA Breakthrough Therapy designation for its Tafinlar® (dabrafenib)

Marks GSK’s fourth Breakthrough Therapy designation London, UK, 17-1-2014 — /EuropaWire/ —  GlaxoSmithKline plc (LSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Tafinlar®(dabrafenib) for treatment of patients with metastatic BRAF V600E … Read the full press release