The application was supported by data from Phase III study of trametinib monotherapy compared to dacarbazine monotherapy conducted in metastatic melanoma patients with BRAF V600 mutation.
Data from a Phase I/II study comparing dabrafenib monotherapy to combination therapy with dabrafenib and trametinib in BRAF V600 mutation positive metastatic melanoma patients was also included in the application.
GSK oncology R&D head Dr Rafael Amado said, "We initiated a randomised study very early in the development programme to test whether the novel-novel combination could circumvent resistance to single agent anti-BRAF therapy and are encouraged by the results from this Phase I/II trial."
Of the three randomised trials included in a current Phase III development programme for the combination in BRAF V600 mutation positive melanoma, two trials are in the metastatic setting while one trial is in the adjuvant setting.