EU nod for Taf-Mek combo for adjuvant melanoma therapyOctober 10, 2018
The EC has approved dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of stage III patients with BRAF V600 mutation-positive melanoma after complete surgical resection.
The approval is based on results from the Phase III COMBI-AD global study, which enrolled more than 870 patients with stage III, BRAF V600E/K-mutant melanoma without prior anticancer therapy, and who were randomized within 12 weeks of complete surgical resection.
The BRAF gene provides instructions for making a protein that
helps transmit chemical signals from outside the cell to the cell’s nucleus. This protein is part of a signalling pathway known as the RAS/MAPK pathway, which controls several important cell functions. Specifically, the RAS/MAPK pathway regulates the proliferation of cells, the process by which cells mature to carry out specific functions, migrations and apotheosis.
This approval is the third for Tafinlar in combination with Mekinist in Europe across a variety of tumour types identified with a high level of BRAF mutation, Novartis said.
Combination use of Tafinlar + Mekinist in patients with unresectable or metastatic melanoma who have a BRAF V600 mutation is approved in the US, EU, Japan, Australia, Canada and other countries.
The combination of Tafinlar + Mekinist is also approved for the treatment of metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation in the US and advanced NSCLC with a BRAF V600 mutation in the EU.