29 August 2018 - Approval based on COMBI-AD study demonstrating greater than 50% reduction in risk of disease recurrence or death in stage III melanoma patients.
Novartis announced today that the European Commission has approved Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of stage III patients with BRAF V600 mutation-positive melanoma after complete surgical resection.
This approval is the third for Tafinlar in combination with Mekinist in Europe across a variety of tumour types identified with a high level of BRAF mutation. It also demonstrates Novartis leadership in BRAF+ targeted therapy, and to date, more than 60,000 patients worldwide have been treated with the combination therapy across four indications.