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

Novartis combination adjuvant therapy Tafinlar + Mekinist receives FDA Breakthrough Therapy Designation for stage III BRAF V600 mutation-positive melanoma patients. 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 First targeted combination therapy to demonstrate a clinical benefit in patients with a BRAF V600E/K mutation in the adjuvant setting Discussions with global regulatory authorities are ongoing - 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 following complete resection. Tafinlar in combination with Mekinist is in development to become the first adjuvant treatment specifically for melanoma patients with a BRAF V600 mutation. The designation is based on results from COMBI-AD, a Phase III study of 870 patients with stage III BRAF V600E/K mutation-positive melanoma after complete surgical resection treated with Tafinlar + Mekinist. Patients received the Tafinlar (150 mg BID) + Mekinist (2 mg QD) combination (n = 438) or matching placebos (n = 432) . After a median follow-up of 2.8 years, the primary endpoint of relapse-free survival (RFS) was met.