Posted by Michael Wonder on 22 Dec 2017
Novartis' combination therapy Tafinlar and Mekinist granted FDA priority review for the adjuvant treatment of stage III BRAF V600 mutation-positive melanoma
22 December 2017 - Priority review designation based on Phase III study showing 53% reduction in risk of recurrence or death with Tafinlar and Mekinist, as compared to placebo.
Novartis announced today the US FDA has accepted the Company's supplemental new drug application for filing, and granted Priority Review designation for Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with stage III melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, following complete resection. In October, the FDA also granted breakthrough therapy designation to Tafinlar in combination with Mekinist for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following complete resection.
Priority review designation is based on results from COMBI-AD, a Phase III study evaluating Tafinlar and Mekinist in patients with stage III BRAF V600E/K mutation-positive melanoma after complete resection.
