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Adjuvant Dabrafenib/Trametinib Approved in Europe for BRAF+ Melanoma

Jason M. Broderick @jasoncology
Published: Wednesday, Aug 29, 2018

Liz Barrett

Liz Barrett

The European Commission has approved the combination of dabrafenib (Tafinlar) and trametinib (Mekinist) for the adjuvant treatment of patients with BRAF V600–positive stage III melanoma following complete resection, according to Novartis, the manufacturer of both agents.

Adverse events (AEs) were experienced by 97% of those treated with dabrafenib and trametinib versus 88% with placebo. The rates of grade 3/4 AEs were 41% and 14% for the combination and placebo, respectively. Overall, AEs led to discontinuation for 26% of those in the combination arm versus 3% with placebo. The most common all-grade AEs, which were mostly grade 1/2, with the combination were pyrexia (63%), fatigue (47%), and nausea (40%). There were no fatal adverse events with the combination of dabrafenib and trametinib.

References

  1. Hauschild A, Santinami M, Long GV, et al. COMBI-AD: Adjuvant dabrafenib (D) plus trametinib (T) for resected stage III BRAF V600E/K–mutant melanoma. Presented at: 2017 ESMO Congress; Madrid, Spain; September 8-12, 2017. Abstract LBA6_PR.
  2. Long GV, Hauschild A, Santinami M, et al. Adjuvant Dabrafenib plus Trametinib in Stage III BRAF-Mutated Melanoma. N Engl J Med. Published online September 10, 2017. DOI: 10.1056/NEJMoa1708539.

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TitleExpiration DateCME Credits
Advances in™ Melanoma: Exploring BRAF/MEK in Adjuvant and Neoadjuvant SettingsSep 28, 20191.5
Medical Crossfire®: What Does Data Tell Us About How to Optimize Checkpoint Inhibitor Strategies Across Lines of Care for Patients with Melanoma?Nov 30, 20191.5
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