For Healthcare Professionals Outside the US

For patients with BRAF V600 mutation–positive unresectable or metastatic melanoma

For patients with BRAF V600 mutation–positive advanced non-small cell lung cancer (NSCLC)

Adverse events data from clinical trials

Tafinlar + Mekinist demonstrated a consistent safety profile across 2 phase 3 studies1,2Most common adverse events Tafinlar® (dabrafenib) + Mekinist® (trametinib) phase 3 studies

  • The most common Tafinlar + Mekinist adverse reactions (≥ 20%) were pyrexia, fatigue, nausea, headache, chills, diarrhea, rash, arthralgia, hypertension, vomiting, and cough3
  • Pyrexia was the most common AE with Tafinlar + Mekinist (52%-57% overall, 5%-7% grade 3)1,2
    • The discontinuation rate due to pyrexia was 2%-5% across the phase 3 studies1,2

Tafinlar + Mekinist was associated with fewer secondary malignancies and skin-related AEs vs BRAF inhibitor monotherapy1,2

Tafinlar® (dabrafenib) + Mekinist® (trametinib) less common adverse events of interest

  • The combination of Tafinlar + Mekinist was associated with a decrease in the incidence of secondary malignancies and select skin toxicities, which are associated with the paradoxical activation of the MAPK pathway via BRAF inhibitor monotherapy1,2
  • In COMBI-v, the risk of phototoxicity with Tafinlar + Mekinist was much lower than that of vemurafenib1

AE, adverse event; cuSCC, cutaneous squamous cell carcinoma; MAPK, mitogen-activated protein kinase.


Safety information

References: 1. 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; October 7-11, 2016; Copenhagen, Denmark. 2. Long GV, Stroyakovskiy D, Gogas H, et al. Dabrafenib and trametinib versus dabrafenib and placebo for Val600 BRAF-mutant melanoma: a multicentre, double-blind, phase 3 randomised controlled trial. Lancet. 2015;386(9992):444-451. 3. Tafinlar (dabrafenib) [summary of product characteristics]. West Sussex, UK: Novartis Europharm Limited; 2016.