Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The European Medicines Agency (EMA's) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for GlaxoSmithKline (GSK's) Mekinist (trametinib) as a single agent in the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Subscribe to our email newsletter
Trametinib as a single agent has not showed clinical activity in patients who have progressed on a prior BRAF inhibitor therapy.
According to the company, before taking trametinib, patients must have confirmation of BRAF V600 mutation using a validated test.
GSK head of Oncology R&D Rafael Amado said, "This CHMP opinion brings us a step closer to making another personalised medicine available for patients with BRAF-mutant metastatic melanoma in Europe."
The recommendation for trametinib monotherapy is based on a randomized open label Phase III trial comparing trametinib to chemotherapy in 322 patients with BRAF mutant melanoma (V600E and V600K) and a non-randomized Phase II trial in 97 patients with BRAF mutant melanoma split in two cohorts: previously treated or not treated with a BRAF inhibitor.
CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission (EC) and a final decision is expected during the second quarter of 2014.