LONDON, March 26 (Reuters) - A combination treatment fromGlaxoSmithKline for melanoma, the deadliest form of skincancer, has been delayed in Europe after regulators said theyneeded more information.
Britain's biggest drugmaker said on Wednesday it hadwithdrawn its application and would re-submit its filing for thecombined use of Tafinlar, also known as dabrafenib, andMekinist, or trametinib, once it had additional results from anongoing Phase III clinical trial.
The reluctance of the European Medicines Agency to approvethe combination based on Phase II data, plus some limited PhaseIII results, contrasts with the stance of the U.S. Food and DrugAdministration, which gave the treatment accelerated approval inJanuary.
Tafinlar is already approved in Europe, while Mekinist isstill being reviewed. GSK believes the two drugs will have alonger-lasting effect if given together. Industry analysts alsosee a combination offering the greatest commercial potential.
Tafinlar, which is similar to Roche's rivalmedicine Zelboraf, is designed to work in patients with amutation of a gene known as BRAF. So-called BRAF inhibitors havebeen remarkably effective in shrinking melanoma tumours but mostpatients eventually develop resistance to the drugs.
By combining Tafinlar with Mekinist, which works in adifferent way, the hope is that the cancer will be held at bayfor longer.
Melanoma is diagnosed in nearly 160,000 people worldwideeach year. It can spread quickly to internal organs and averagesurvival is six to nine months. (Reporting by Ben Hirschler; Editing by Pravin Char)
Glaxosmithkline (GSK)