European Commission approves Novartis combination therapy Tafinlar + Mekinist 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 -   EC approval marks third indication in Europe for leading BRAF/MEK inhibitor combination Tafinlar + Mekinist Basel, August 29, 2018 - Novartis announced today that the European Commission (EC) 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 tumor 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. "Novartis' deep therapeutic knowledge and our ability to apply novel approaches to the development of new medicines has resulted again in a new treatment advance for melanoma patients," said Liz Barrett, CEO, Novartis Oncology. "The European approval of the Tafinlar and Mekinist combination illustrates Novartis' continued efforts to reimagine cancer by providing a highly effective, targeted therapy for earlier-stage melanoma patients." The approval is based on results from the Phase III COMBI-AD global study, which enrolled more than 870 patients with stage III, BRAF V600E/K-mutant melanoma without prior anticancer therapy, and who were randomized within 12 weeks of complete surgical resection.