May 7, 2018

FDA Approves Tafinlar® + Mekinist® for Adjuvant Treatment of BRAF V600-mutant Stage III Melanoma


CancerConnect News: The US Food and Drug Administration (FDA) has approved Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) for the adjuvant treatment of patients with stage III melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test.1

About Melanoma 

Stage III melanoma includes cancers of any thickness that have spread to the regional lymph nodes. The extent or amount of tumor in the lymph nodes is the most important prognostic factor for patients with stage III melanoma.  Historically, melanoma has had a poor outlook however, recent treatments that have been targeted towards specific genetic mutations, as well as those that stimulate the immune system have resulted in significantly improved outcomes for many patients with this disease.  There are about 200,000 individuals with advanced melanoma diagnosed worldwide each year, approximately half of which have the BRAF mutation, a key target in the treatment of metastatic melanoma.2

About Tafinlar + Mekinist Combination

Tafinlar and Mekinist are both precision cancer medicines referred to as kinase inhibitors. They block the action of certain biochemical pathways involved in the growth and spread of cancer cells.  Treatment with tafinlar targets the BRAF V600E mutation and mekinst targets the BRAF V600E or V600K mutations. When tafinlar is used with mekinist, the combination has been shown to slow tumor growth more than either drug alone. The combination of Tafinlar + Mekinist was approved for the treatment of advanced melanoma by the FDA in 2014.3

The current melanoma approval is based on results from COMBI-AD clinical trial in 870 patients with stage III BRAF V600E/K mutation-positive melanoma treated with Tafinlar + Mekinist after complete surgical resection. Treatment with the combination therapy significantly reduced the risk of disease recurrence or death by 53% as compared to individuals not treated with adjuvant therapy.  At a median follow-up of 2.8 years, the estimated 3-year rate of relapse-free survival was 58% in the combination-therapy group and 39% in the placebo. The 3-year overall survival rate was 86% in the combination-therapy group compared to 77%.4

Precision cancer medicines continue to expand the treatment options for individuals diagnosed with melanoma and patients should ensure they discuss the role of genomic testing with their treating physician in order to determine if they are eligible for the combination of Mekinst and Tafinlar or other targeted therapies.


  2. Cancer Facts & Figures 2017. American Cancer Society website. Availableat:

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Tags: adjuvant treatment, BRAF V600E, dabrafenib, mekinist, Melanoma, News, precision cancer medicines, stage III, tafinlar, trametinib, Uncategorized, V600K mutations