New melanoma treatment recommended for approval in Europe

New melanoma treatment recommended for approval in Europe

25 Apr 2014

European regulators have recommended the drug Mekinist (trametinib) for approval as a treatment for unresectable or metastatic melanoma in patients with a mutation of a gene known as BRAF.

The medicine is already approved in the United States, where regulators have also given a green light to a combination of Mekinist and another GlaxoSmithKline drug called Tafinlar for treating melanoma.

By combining the two medicines, which work in a different ways, GlaxoSmithKline believes that melanoma (the deadliest form of skin cancer) can be held at bay for longer. This combination faces a delay in Europe, however, where regulators (the European Medicines Agency, or EMA) are seeking more information.

Recommendations for marketing approval by the EMA's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.

 

Source: Reuters: http://www.reuters.com/article/2014/04/25/pharmaceuticals-europe-idINL6N0NH3ZS20140425