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FDA Approves Adjuvant Dabrafenib/Trametinib for BRAF+ Melanoma

Jason M. Broderick @jasoncology
Published: Monday, Apr 30, 2018

John M. Kirkwood, MD

John M. Kirkwood, MD
The FDA has approved the combination of dabrafenib (Tafinlar) and trametinib (Mekinist) for the adjuvant treatment of patients with BRAF V600E– or V600K–positive stage III melanoma following complete resection.

V600E/K stage III melanoma to receive dabrafenib plus trametinib (n = 438) or placebo (n = 432). All patients were within 12 weeks of complete surgical resection and had stage IIIa (18%), IIIb (41%), and IIIc (40%) disease. Dabrafenib was given at 150 mg twice daily with trametinib at 2 mg once daily for 12 months. The salvage therapies received following the study were similar in each arm, and, in some cases, included a rechallenge with BRAF/MEK inhibition.

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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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