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.

It looks like you are using an older version of Internet Explorer which is not supported. We advise that you update your browser to the latest version of Microsoft Edge, or consider using other browsers such as Chrome, Firefox or Safari.

Home > Safety > Metastatic BRAF V600+ Melanoma > Safety Profile
For first-line targeted therapy in patients with BRAF V600 positive metastatic melanoma

Among the most common AEs, none were considered irreversible or long-term1-3*

MOST COMMON AEs

No new safety signals at 5 years in the pooled analysis4

• 6% incidence of Grade 3 pyrexia and no Grade 45 
• No deaths due to treatment-related adverse events4 

Most common adverse events TAFINLAR® (dabrafenib) and MEKINIST® (trametinib) phase 3 studies

Select AEs observed with other targeted therapies are infrequent with TAFINLAR + MEKINIST

• Photosensitivity was less frequent and less severe vs vemurafenib6 
• No clinically relevant QTc prolongation with TAFINLAR or MEKINIST5,7

border line

A consistent safety profile that offers you and your patients the confidence of an established management approach

border line

AEs DECLINE OVER TIME

Incidence of AEs decline over time1

Incidence of AEs (≥15%) over time in patients who received TAFINLAR + MEKINIST ≥36 months (n=50)8

Adverse event incidences for TAFINLAR® (dabrafenib) + MEKINIST® (trametinib) patients

ABOUT PYREXIA

3 facts to know about TAFINLAR + MEKINIST and pyrexia in COMBI-d/v

Understanding pyrexia: 3 simple facts
border line

Up to 96% of patients who experienced pyrexia with TAFINLAR + MEKINIST were able to continue treatment by following three easy steps.12,13

border line
  • 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 monotherapy12,13
  • In COMBI-v, the risk of phototoxicity with TAFINLAR + MEKINIST was much lower than that of vemurafenib12
AE, adverse event; MAPK, mitogen-activated protein kinase.
*Please see prescribing information for serious AEs that may occur with TAFINLAR + MEKINIST.

Safety information

References: 1. Atkinson VG, Hauschild A, Santinami M, et al. Adverse events (AEs) over time in patients (pts) treated with adjuvant dabrafenib plus trametinib (D + T) or placebo (Pbo) in the COMBI-AD trial. Presented at: ESMO 2018 Congress; October 19-23, 2018; Munich, Germany. 2. Data on file. Tafinlar + Mekinist Clinical Study Report. Novartis Pharmaceutical Corp; 2018. 3. 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. 4. Robert C, Grob JJ, Stroyakovskiy D, et al. Five-year outcomes with dabrafenib plus trametinib in metastatic melanoma. Appendix. N Engl J Med. 2019;381(7):626-636. 5. Tafinlar Summary of Product Characteristics. Novartis Pharmaceuticals Corp; 2020. 6. Robert C, Karaszewska B, Schachter J, et al. Improved overall survival in melanoma with combined dabrafenib and trametinib. N Engl J Med. 2015;372(1):30-39. 7. Mekinist Summary of Product Characteristics. Novartis Pharmaceuticals Corp; 2020. 8. Grob JJ, Flaherty KT, Long GV. Pooled analysis of safety with extended 3-year follow-up across combination dabrafenib and trametinib phase 3 trials. Presented at the Society for Melanoma Research; November 6-9, 2016; Boston, MA. 9. Data on file. Clinical study report. MEK116513. Novartis Pharmaceuticals Corp; 2020. 10. Data on file. Clinical study report. MEK115306. Novartis Pharmaceuticals Corp; 2016. 11. Schadendorf D, Hauschild A, Santinami M, et al. Patient-reported outcomes in patients with resected, high-risk melanoma with BRAFV600E or BRAFV600K mutations treated with adjuvant dabrafenib plus trametinib (COMBI-AD): a randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2019;20(5):701-710. 12. 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. 13. 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.

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)
imgh22

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