GlaxoSmithKline (GSK) plc has submitted a supplemental New Drug Applications (NDAs) to the US Food and Drug Administration for use of dabrafenib, a BRAF inhibitor, in combination with trametinib, a MEK inhibitor. Supplemental applications were submitted to each of the currently approved NDAs for the use of each drug in combination with the other, for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 E or K mutation.
The applications are based on data from a randomised phase I/II study comparing dabrafenib monotherapy to combination therapy with dabrafenib and trametinib in patients with BRAF V600E and V600K mutation positive metastatic melanoma.
Use of dabrafenib and trametinib in combination is investigational and not approved anywhere in the world. European review of the MAA submission for trametinib, both as monotherapy and in combination with dabrafenib, is ongoing. CHMP has reverted from the accelerated assessment review process to standard timelines to allow sufficient time for review of the submission.