GlaxoSmithKline has announced regulatory submissions on both sides of the Atlantic for two skin cancer treatments.
First up, applications have been filed in Europe and the USA for dabrafenib for the treatment of adults with unresectable or metastatic melanoma with a BRAF V600 mutation. GSK has also submitted trametinib to the US Food and Drug Administration for the same indication and a filing is planned to the European Medicines Agency in the coming months.
GSK has been working with bioMerieux since 2010 to develop a molecular theranostic test to detect BRAF V600 mutations which are found in several cancers including melanoma. The French company has filed for FDA pre-market approval of the test which is currently being utilised in the Phase III trametinib-dabrafenib combination programme.
The latter will pit dabrafenib-trametinib against Roche's already-approved BRAF inhibitor Zelboraf (vemurafenib) in a head-to-head trial aimed at finding out which treatment improves the overall survival of patients with metastatic melanoma the most.