GlaxoSmithKline’s Trametinib Granted Quick Review by EMA

The European Medicines Agency (EMA) has granted GlaxoSmithKline’s (GSK) melanoma drug an accelerated review.

The melanoma drug, a MEK inhibitor named trametinib, is requesting a European licence as both a monotherapy and in combination with their investigational BRAF inhibitor dabrafenib, for the medication of patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has granted GlaxoSmithKline’s application for accelerated assessment, meaning that the drug could be available in the market within six months, if it is approved.

The application to the European Medicines Agency contains data from a Phase III study of trametinib monotherapy in comparison to the established chemotherapy agents dacarbazine or paclitaxel monotherapy in patients with BRAF V600 mutation positive metastatic melanoma

The application also contains data from a randomised Phase I/II study which compared dabrafenib monotherapy to combination therapy with dabrafenib and trametinib, in patients with BRAF V600 mutation positive metastatic melanoma

Dr Rafael Amado, the head of oncology R&D at GSK, explained that the company “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.”

“We are planning further regulatory submissions based on these data, in the US and other countries in the coming months,” Amado added.

An application which has been granted accelerated assessment has a maximum review time of 150 days, although the CHMP can prolong this if necessary.


Industry News