Posted by Michael Wonder on 30 Apr 2018
Novartis receives FDA approval of Tafinlar and Mekinist for adjuvant treatment of BRAF V600-mutant melanoma
30 April 2018 - New indication represents a new treatment option for patients in the US with BRAF mutation-positive melanoma at risk of disease recurrence or metastases, and is currently under regulatory review in Europe, Japan, Canada and other countries worldwide.
Novartis announced today that the US 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 and Mekinist after complete surgical resection.
