UPDATE 1-EU agency backs approval of new GlaxoSmithKline melanoma drug

Fri Apr 25, 2014 11:19am EDT

(Adds details on GSK drug)

LONDON, April 25 (Reuters) - GlaxoSmithKline's melanoma drug Mekinist - one of several drugs being sold to Novartis under an asset swap deal - has been recommended for approval by European regulators.

The European Medicines Agency (EMA) said on Friday its experts had backed the drug, also known as trametinib, as a treatment for unresectable or metastatic melanoma in patients with a mutation of a gene known as BRAF.

The watchdog also endorsed wider use of Bayer's Nexavar as a treatment for thyroid cancer.

Mekinist is one of three GSK cancer drugs that Novartis believes each have the potential to generate more than $1 billion a year in sales under its ownership.

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

By combining the two medicines, which work in a different ways, GSK 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 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. (Reporting by Ben Hirschler. Editing by Jane Merriman)

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