Dr. Postow on FDA Approval of Adjuvant Dabrafenib Plus Trametinib in BRAF-Mutant Melanoma

Michael A. Postow, MD
Published: Monday, Apr 30, 2018



Michael A. Postow, MD, medical oncologist, Memorial Sloan Kettering Cancer Center, discusses the FDA approval of dabrafenib (Tafinlar) plus trametinib (Mekinist) as an adjuvant treatment for patients with BRAF V600E– or V600K–positive stage III melanoma following complete resection.

The FDA recently approved the combination of dabrafenib and trametinib for the adjuvant treatment of patients with BRAF V600E– or V600K–positive stage III melanoma following complete resection.

The approval is based on data from the phase III COMBI-AD trial, in which adjuvant treatment with dabrafenib and trametinib was found to reduce the risk of relapse or death by 53% versus placebo for patients with BRAF-mutant stage III melanoma. After a median follow-up of 2.8 years, the 3-year relapse-free survival rate with dabrafenib and trametinib was 58% versus 39% for placebo (HR, 0.47; 95% CI, 0.39-0.58; P <.001).
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Michael A. Postow, MD, medical oncologist, Memorial Sloan Kettering Cancer Center, discusses the FDA approval of dabrafenib (Tafinlar) plus trametinib (Mekinist) as an adjuvant treatment for patients with BRAF V600E– or V600K–positive stage III melanoma following complete resection.

The FDA recently approved the combination of dabrafenib and trametinib for the adjuvant treatment of patients with BRAF V600E– or V600K–positive stage III melanoma following complete resection.

The approval is based on data from the phase III COMBI-AD trial, in which adjuvant treatment with dabrafenib and trametinib was found to reduce the risk of relapse or death by 53% versus placebo for patients with BRAF-mutant stage III melanoma. After a median follow-up of 2.8 years, the 3-year relapse-free survival rate with dabrafenib and trametinib was 58% versus 39% for placebo (HR, 0.47; 95% CI, 0.39-0.58; P <.001).



View Conference Coverage
Online CME Activities
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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