For Healthcare Professionals Outside the US
Tafinlar + Mekinist is indicated for adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection; for first-line treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation; for adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation.

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Home > About > BRAF V600+ Melanoma > Clinical Features
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BRAF mutation is an oncogenic driver in approximately 50% of people with melanoma2

Overall survival in adjuvant setting without treatment by BRAF status
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Without intervention, nearly half of patients with resected BRAF+ melanoma relapsed within 1 year6

Relapse rates in adjuvant melanoma with and without treatment

BRAF V600 mutations result in constitutive activation of the MAPK pathway, which promotes cell growth and proliferation1

BRAF metastatic melanoma overall survival

BRAF mutational testing is recommended for patients with Stage III or IV melanoma and should be mandatory in patients with advanced disease as stated by the European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for Cutaneous Melanoma7

Patients with BRAF V600–mutant metastatic melanoma may have more aggressive disease than BRAF wild-type patients3,4

BRAF metastatic melanoma overall survival

Long GV, et al. J Clin Oncol. 2011;29(10):1239-1246. Reprinted with permission. © 2011 American Society of Clinical Oncology. All rights reserved.

  • Patients with BRAF V600–mutant melanoma not treated with targeted therapy had worse survival outcomes vs patients with BRAF wild-type melanoma3
    • Patients with BRAF V600–mutant melanoma who received targeted therapy had similar survival outcomes vs patients without the BRAF mutation3
  • Patients with BRAF V600–mutant melanoma tended to have high-risk characteristics, such as an early onset of disease and presence of mitoses3
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Take action early with therapy that’s tailored to your BRAF+ patient.

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ERK, extracellular signal–regulated kinase; MAPK, mitogen-activated protein kinase; MEK, MAPK/ERK kinase; OS, overall survival; WT, wild type. 
References: 1. Tafinlar Summary of Product Characteristics. Novartis Pharmaceuticals Corp; 2020. 2. Vultur A, Villanueva J, Herlyn M. Targeting BRAF in advanced melanoma: a first step toward manageable disease. Clin Cancer Res. 2011;17(7):1658-1663. 3. Long GV, Menzies AM, Nagrial AM, et al. Prognostic and clinicopathologic associations of oncogenic BRAF in metastatic melanoma. J Clin Oncol. 2011;29(10):1239-1246. 4. Hugdahl E, Kalvenes MB, Puntervoll HE, Ladstein RG, Akslen LA. BRAF-V600E expression in primary nodular melanoma is associated with aggressive tumour features and reduced survival. Br J Cancer. 2016;114(7):801-808. 5. Corrie PG, Marshall A, Nathan PD, et al. Adjuvant bevacizumab as treatment for melanoma patients at high risk of recurrence: final results of the AVAST-M trial. Presented at: 2017 ASCO Annual Meeting; June 2-6, 2017; Chicago, IL. 6. Long GV, Hauschild A, Santinami M, et al. Adjuvant dabrafenib plus trametinib in stage III BRAF-mutated melanoma. N Engl J Med. 2017;377(19):1813-1823.7. Michielin O, van Akkooi ACJ, Ascierto PA. Cutaneous melanoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annal Oncol. 2019;30:1884–1901.

COVID-19 Update


Novartis is closely monitoring the evolving COVID-19 pandemic. For the most recent information on how Novartis is responding, visit the COVID-19 Information Center.

During this time of uncertainty it is important to communicate with your patients about COVID-19 to clarify that they should not stop their treatments except under the direction of the treating physician, and to ensure that patients have sufficient drug to avoid any treatment interruptions.

Reach out to your Novartis representative with any questions related to Novartis products.

04/20  G-ONC-1230566

COMBI-AD was a double-blind, placebo-controlled, Phase 3 trial that compared Tafinlar + Mekinist vs placebo4

ELIGIBILITY REQUIREMENTS

  • Resection of histologically confirmed Stage IIIA, B, or C with BRAF V600E or BRAF V600K mutation
  • ECOG performance status ≤1
  • No prior systemic anticancer treatment or radiotherapy for melanoma
TAFINLAR 150 mg BID + MEKINIST
2 mg QD (n=438)
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Placebo (n=432)

STUDY ENDPOINTS

  • Primary endpoint was RFS
  • Secondary endpoints were OS, distant metastasis-free survival, freedom from relapse, and safety
COMBI-d phase 3 study: Tafinlar® (dabrafenib) + Mekinist® (trametinib) vs Tafinlar® monotherapy