GlaxoSmithKline has submitted a marketing authorisation application to the European Medicines Agency (EMA) for approval of its new melanoma drug trametinib.
The compound is intended for use as a monotherapy and in combination with dabrafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
“GlaxoSmithKline has submitted its new personalised melanoma therapy trametinib for approval by the European Medicines Agency.“
GlaxoSmithKline's request for accelerated assessment of this application has already been approved by the EMA's Committee for Medicinal Products for Human Use (CHMP), based on encouraging data from clinical trials.
An application that has been granted accelerated assessment will have a maximum review time of 150 days, though this could be extended should the CHMP or GlaxoSmithKline deem it appropriate.
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."
Last week, the company announced its support for AllTrials, a campaign aimed at improving clinical trial transparency within the pharmaceutical industry.