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US Residents | Summary of Product Characteristics: Tafinlar Mekinist | Safety Information

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; or for adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation.

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EFFICACY SAFETY

Only metastatic melanoma therapy to demonstrate both extended survival and improved quality of life when used in the first line3-6

Across 2 phase 3 studies, Tafinlar + Mekinist demonstrated overall survival rates of 44% to 45% at 3 years3,4

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Practice-changing results of the Phase III COMBI-AD clinical trial expand the Tafinlar + Mekinist indication into adjuvant therapy

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Choose Tafinlar + Mekinist first-line for your adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation

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Tafinlar + Mekinist is the first and only approved targeted therapy to treat adult patients with BRAF V600+ NSCLC1,2

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OS, overall survival; QOL, quality of life.

References: 1. Tafinlar Summary of Product Characteristics. Novartis Pharmaceuticals Corp; 2017. 2. Mekinist Summary of Product Characteristics. Novartis Pharmaceuticals Corp; 2017. 3. Flaherty KT, Davies MA, Grob J, et al. Genomic analysis and 3-year efficacy and safety update of COMBI-d. J Clin Oncol. 2016;34(suppl) [abstract 9502]. 4. Robert C, Karaszewska B, Schachter J, et al. Three-year estimate of overall survival in COMBI-v, a randomized phase 3 study evaluating first-line dabrafenib + trametinib in patients with unresectable or metastatic BRAF V600E/K–mutant cutaneous melanoma. Presented at: European Society for Medical Oncology Annual Meeting; October 7-11, 2016; Copenhagen, Denmark. 5. Schadendorf D, Amonkar MM, Stroyakovskiy D, et al. Health-related quality of life impact in a randomised phase III study of the combination of dabrafenib and trametinib versus dabrafenib monotherapy in patients with BRAF V600 metastatic melanoma. Eur J Cancer. 2015;51(7):833-840. 6. Grob J-J, Amonkar MM, Karaszewska B, et al. Comparison of dabrafenib and trametinib combination therapy with vemurafenib monotherapy on health-related quality of life in patients with unresectable or metastatic cutaneous BRAF Val600-mutation-positive melanoma (COMBI-v): results of a phase 3, open-label, randomised trial. Lancet Oncol. 2015;16(13):1389-1398.

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IMPORTANT: The information on this website is based on the European Summary of Product Characteristics (EUSmPC)

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The clinical use of these resources may not be consistent with the approved indications for Tafinlar® (dabrafenib) + Mekinist® (trametinib). The information in these resources is not country specific and may contain information that is outside the approved indications where you practice. Please contact your local Novartis representative for the latest product information specific to your country.