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Dr. Weber on the FDA Approval of Adjuvant Dabrafenib/Trametinib in BRAF-Mutant Melanoma

Jeffrey S. Weber, MD, PhD
Published: Monday, Apr 30, 2018



Jeffrey S. Weber, MD, PhD, the Laura and Isaac Perlmutter Professor of Oncology, co-director of the Melanoma Research Program, deputy director of the Perlmutter Cancer Center, NYU Langone Medical Center, and a 2016 Giant of Cancer Care® in Melanoma, 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 has 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).


Jeffrey S. Weber, MD, PhD, the Laura and Isaac Perlmutter Professor of Oncology, co-director of the Melanoma Research Program, deputy director of the Perlmutter Cancer Center, NYU Langone Medical Center, and a 2016 Giant of Cancer Care® in Melanoma, 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 has 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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