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 > Safety > Adjuvant BRAF V600+ Melanoma > Safety Profile
For the adjuvant treatment of Stage III BRAF V600 positive melanoma following complete resection

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

  • AEs generally appear early during the first 3 months and then decrease in incidence1,2 
  • Safety was consistent across indications1
Adjuvant safety consistent with metastatic trials
  • The majority of patients completed the scheduled 12 months of TAFINLAR + MEKINIST at the intended daily dose2,3
  • Discontinuation rate due to AEs with TAFINLAR + MEKINIST was 26% (vs 3% for placebo)3
    • The most common cause of discontinuation was mild or moderate pyrexia (Grade 1 or 2)2
    • Discontinuation may have been influenced by the nature of adjuvant treatment3
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Guide the way for your patients with an established and predictable safety profile

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AE, adverse event.
*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.

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