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# FDA Approves Novartis NDA for Tafinlar
- URL: https://www.fdaweb.com/fda-approves-novartis-nda-for-tafinlar/
- Published: 2018-05-01T12:00:00.000Z
- Updated: 2026-09-15T00:02:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141339

FDA has approved a Novartis NDA for Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, and involvement of lymph nodes, following complete resection. Approval was based on data from COMBI-AD, a Phase 3 study of 870 patients with Stage 3 BRAF V600E/K mutation-positive melanoma. “After a median follow-up of 2.8 years, the primary endpoint of relapse-free survival (RFS) was met,” the company says. “Treatment with the combination therapy significantly reduced the risk of disease recurrence or death by 53% as compared to placebo.” It adds that improvements were also seen in key secondary endpoints including overall survival, distant metastasis-free survival and freedom from relapse.