GSK melanoma drug combination faces delay in Europe

Source: Reuters, March 2014

(Reuters) – A combination treatment from GlaxoSmithKline for melanoma, the deadliest form of skin cancer, has been delayed in Europe after regulators said they needed more information.

Britain’s biggest drugmaker said on Wednesday it had withdrawn its application and would re-submit its filing for the combined use of Tafinlar, also known as dabrafenib, and Mekinist, or trametinib, once it had additional results from an ongoing Phase III clinical trial.

The reluctance of the European Medicines Agency to approve the combination based on Phase II data, plus some limited Phase III results, contrasts with the stance of the U.S. Food and Drug Administration, which gave the treatment accelerated approval in January.

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. Industry analysts also see a combination offering the greatest commercial potential.

Tafinlar, which is similar to Roche’s rival medicine Zelboraf, is designed to work in patients with a mutation of a gene known as BRAF. So-called BRAF inhibitors have been remarkably effective in shrinking melanoma tumours but most patients eventually develop resistance to the drugs.

By combining Tafinlar with Mekinist, which works in a different way, the hope is that the cancer will be held at bay for longer.

Melanoma is diagnosed in nearly 160,000 people worldwide each year. It can spread quickly to internal organs and average survival is six to nine months. (Reporting by Ben Hirschler; Editing by Pravin Char)