FDA approves Tafinlar + Mekinist for adjuvant treatment of BRAF V600-mutant melanoma.- Novartis.

Novartis has announced that the FDA has approved Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. The FDA granted the combination Breakthrough Therapy Designation for this indication in October 2017 and Priority Review in December 2017.

The melanoma approval is based on results from COMBI-AD, a Phase III study of 870 patients with Stage III BRAF V600E/K mutation-positive melanoma treated with Tafinlar + Mekinist after complete surgical resection. Patients received the Tafinlar (150 mg BID) + Mekinist (2 mg QD) combination (n = 438) or matching placebos (n = 432)[1]. After a median follow-up of 2.8 years, the primary endpoint of relapse-free survival (RFS) was met. Treatment with the combination therapy significantly reduced the risk of disease recurrence or death by 53% as compared to placebo (HR: 0.47 [95% CI: 0.39-0.58]; p<0.0001; median not reached with combination therapy vs. 16.6 months with placebo). the rfs benefit among the combination arm was observed across all patient subgroups, including disease sub-stage. improvements were also observed in key secondary endpoints including overall survival (os), distant metastasis-free survival (dmfs) and freedom from relapse (ffr). these results were published in the new england journal of medicine, october 2017.>

See- "Adjuvant Dabrafenib plus Trametinib in Stage III BRAF-Mutated Melanoma"-September 10, 2017 Long G.V., Hauschild A., Santinami M., et al.10.1056/NEJMoa1708539.