In a significant development for melanoma treatment, the European Commission (EC) has granted Novartis approval for its combination therapy of Tafinlar (dabrafenib) and Mekinist (trametinib). This approval is specifically for adjuvant therapy in stage III melanoma patients who are positive for the BRAF V600 mutation and have undergone complete surgical resection.

The approval is based on the compelling findings from the phase 3 COMBI-AD trial, which involved 870 patients with stage III, BRAF V600E/K-mutant melanoma, none of whom had received prior anticancer therapy. This landmark trial demonstrated that the Tafinlar-Mekinist combination significantly reduced the risk of recurrence or death by 53% compared to placebo after a median follow-up of 2.8 years.

Further data from the COMBI-AD trial, with a minimum follow-up of 40 months, reinforced the combination’s efficacy, showing a 51% reduction in the risk of recurrence or death compared to placebo. These results highlight the sustained impact of the therapy on improving patient outcomes.

Liz Barrett, CEO of Novartis Oncology, emphasized the significance of this approval, stating, “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. Our deep therapeutic knowledge and novel approaches to developing new medicines have once again led to a significant treatment advance for melanoma patients.”

Prior to receiving the green light from the EC, the Tafinlar and Mekinist combination was endorsed by the Committee for Medical Products for Human Use of the European Medicines Agency in July. Additionally, the combination had previously secured approval from the US Food and Drug Administration as an adjuvant therapy for melanoma, marking it as a significant treatment option internationally.

This latest EC approval marks the third European endorsement for the Tafinlar-Mekinist combination across various tumor types with a high level of BRAF mutation. It confirms the role of targeted therapies in transforming the treatment landscape for melanoma, offering hope and enhanced outcomes for patients facing this aggressive form of skin cancer.

The EC’s approval of Tafinlar and Mekinist for adjuvant treatment of BRAF V600 mutation-positive melanoma is a testament to the advancements in personalized medicine and targeted cancer therapies. This approach not only enhances the precision of melanoma treatment but also sets a new standard in the care of patients with this challenging condition.

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