(Adds details on GSK drug)
LONDON, April 25 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
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
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
(Reporting by Ben Hirschler. Editing by Jane Merriman)