Tafinlar and Mekinist approved in Europe

Earlier this year the FDA granted approval for Novartis’ combination Tafinlar (dabrafenib) and Mekinist (trametinib) for post-surgery treatment of stage III melanoma patients with BRAF V600 mutations, in order to prevent disease recurrence. Now Novartis have also received approval from the EMA. The decision to grant approval was given in consideration of the COMBI-AD study involving 870 patients. Those who were treated with Novartis’ cancer combination showed statistically significant improvement in relapse-free survival versus those treated with placebo. 38% of those patients relapsed or passed away after the primary data cut-off point of more than two and a half years, and beyond that cut-off, versus 57% of the comparable group of patients.
Competition for this market come from Roche’s combination of Zelboraf (vemurafenib) and Cotellic (cobimetinib).