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Tafinlar (dabrafenib) + Mekinist (trametinib) is associated with an established adverse event profile, and no new safety signals were identified at 5 years1–11
- No new safety signals were seen at 5 years in the COMBI-v/d pooled analysis2
- No treatment-related deaths were reported in this 5 year pooled analysis2
Adverse events observed in the combined COMBI-v/d trials3
- In a separate pooled analysis of the COMBI-v/d trials, adverse event incidence decreased over time in patients completing 36 months of treatment (n=50)1
- The incidence of pyrexia more than halved from 60% at 0–6 months to 12% at 30–36 months of treatment1
Adverse event incidence rates in the combined COMBI-v/d trials1
Please consult Tafinlar and Mekinist SmPCs for full list of adverse events
AE, adverse event; SmPC, Summary of Product Characteristics.
References
- Grob JJ et al. Presented at SMR 2016; 6–9 November, Boston, MA, USA.
- Robert C et al. N Engl J Med 2019;381:626–636.
- Robert C et al. N Engl J Med 2019;381:626–636. Supplementary Table S9.
- Robert C et al. Presented at ESMO 2016; 7–11 October, Copenhagen, Denmark.
- Robert C et al. N Engl J Med 2015;372:30–39.
- Long GV et al. Presented at ASCO 2015; 29 May–2 June, Chicago, IL, USA. J Clin Oncol 2015;33(Suppl):Abstract no.102.
- Long GV et al. Ann Oncol 2017;28:1631–1639. Supplementary Table S3.
- Flaherty KT et al. Presented at 2016 ASCO Annual Meeting: 3–7 June, Chicago, IL, USA.
- Long GV et al. Lancet 2015;386:444–451.
- Welsh SJ and Corrie PG. Ther Adv Med Oncol 2015; 7: 122–136.
- Tafinlar (dabrafenib) Summary of Product Characteristics.
TMC20-C004d May 2020.
