The applications were submitted for the use of each drug dabrafenib, a BRAF inhibitor, and trametinib, a MEK inhibitor, in combination with the other to treat adult patients with unresectable or metastatic melanoma with a BRAF V600 E or K mutation.
Data from a randomised Phase I/II study that compared dabrafenib monotherapy to combination therapy with dabrafenib and trametinib in patients with BRAF V600E and V600K mutation positive metastatic melanoma support the applications.
The MAA of trametinib, both as monotherapy and in combination with dabrafenib, is currently being reviewed in Europe.