For Healthcare Professionals Outside the US

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.

Adjuvant safety consistent with metastatic trials1-3

  • Among the most common AEs, none were irreversible or long-term
    • AEs generally appear early during the first 3 months and then decrease in incidence

 

 

  • The majority of patients completed the scheduled 12 months of Tafinlar + Mekinist at the intended daily dose2,3
  • Discontinuation rate due to AEs was 26% (vs 3% for placebo)2,3
    • The most common cause of discontinuation was mild or moderate pyrexia (Grade 1 or 2)
    • Discontinuation may have been influenced by the nature of adjuvant treatment
  • The most serious adverse events in the treatment arm (≥1%) were pyrexia (15%), chills (3%), ejection fraction decreased (3%), erysipelas (2%), hypotension (1%), cellulitis (1%), and chorioretinopathy (1%)2


AE, adverse event.

 

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; Munich, Germany. 2. Data on file. Novartis Pharmaceuticals 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.