Novartis combination adjuvant therapy Tafinlar® + Mekinist® receives FDA Breakthrough Therapy Designation for stage III BRAF V600 mutation-positive melanoma patients
(WorldNews Switzerland)

Breakthrough Therapy Designation based on Phase III study showing the three-year relapse-free survival (RFS) rate for patients treated with the combination was 58%, compared to 39% with placebo[1] First targeted combination therapy to demonstrate a clinical benefit in patients with a BRAF V600E/K mutation in the adjuvant setting[1] Discussions with global regulatory authorities are ongoing Basel, October 23, 2017- Novartis today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation...