GSK Combined Melanoma Treatment Delayed in Europe

GlaxoSmithKline (GSK), the UK's largest pharmaceutical company, has provisionally withdrawn its marketing authorization application to the European Medicines Agency (EMA) for the combined use of Tafinlar (also known as dabrafenib, Mekinist, or trametinib).

Unlike its U.S. counterpart, Food and Drug Administration (FDA), the European  agency declined to grant accelerated approval of the combined melanoma treatment based on limited data from ongoing Phase III clinical trials.

The company said it would resubmit the application when it has more data.

Tafinlar is already approved in Europe, while Mekinist is still being reviewed. GSK believes the two drugs will have a longer-lasting effect if given together, and industry analysts see a combination offering the greatest commercial potential.

Like Roche's rival medicine Zelboraf, GSK's Tafinlar is a BRAF inhibitor, designed to work in patients with a mutation of a gene known as BRAF. While such drugs have been effective in shrinking melanoma tumors but most patients eventually develop resistance to the drugs, reports said.