GlaxoSmithKline (GSK) has submitted marketing authorisation application, to the European Medicines Agency, for trametinib (MEK) as monotherapy and dabrafenib (BRAF)/MEK combination therapy in metastatic melanoma.
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.
