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NICE approves dabrafenib with trametinib for adjuvant treatment of melanoma

NICE has approved dabrafenib (Tafinlar) with trametinib (Mekinist) as an option for the adjuvant treatment of resected stage III BRAF V600 mutation-positive melanoma in adults.

The approval follows the decision by the European Medicines Agency (EMA) in July to recommend a variation in indications for dabrafenib and trametinib. The EMA granted a position opinion on the use of the combination treatment.

The NICE decision is based on clinical evidence from the Study of the BRAF Inhibitor Dabrafenib in Combination with the MEK Inhibitor Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma after Surgical Resection (COMBI-AD).

The double-blind randomised placebo-controlled trial found that relapse-free survival was substantially longer in the dabrafenib with trametinib arm than in the placebo arm, representing a 53% lower risk of relapse or death (hazard ratio [HR] 0.47; 95% CI 0.39-0.58; P<0.001).

At a median follow-up of 2.8 years, median relapse-free survival had not yet been reached in the treatment arm because of the low event rate.

Median overall survival was not reached in either arm, suggesting that more than 50% of patients were still alive at the time of data cut-off. The hazard ratio for death was 0.57 (95% CI 0.42-0.79; P=0.0006) for dabrafenib with trametinib compared with placebo.

Clinical commissioning groups are required to comply with the NICE recommendation within three months.


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