GlaxoSmithKline submits metastatic melanoma therapies

GlaxoSmithKline has announced it has submitted two therapies for adult patients of metastatic melanoma to the European Medicines Agency.

The pharmaceuticals company applied for a Marketing Authorisation Application to the body for trametinib as monotherapy and in combination with dabrafenib to treat individuals with unresectable or metastatic melanoma with a BRAF V600 mutation.

In addition, the application includes data from a randomised phase III clinical trial of trametinib monotherapy compared to dacarbazine monotherapy in patients with the illness, as well as findings from a randomised phase I/II study comparing the therapies.

The application has been granted accelerated assessment and will have a maximum receive time of 150 days, which can be overturned at any time by the standard centralised procedure assessment timelines of 210 days.

Dr Rafael Amado, head of oncology research and development at GlaxoSmithKline, said: "We are planning further regulatory submissions based on these data, in the US and other countries in the coming months."