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GlaxoSmithKline (GSK) Melanoma Drug Combination Faces Delay In Europe


3/26/2014 7:26:50 AM

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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 Britain's biggest drugmaker said on Wednesday it had withdrawn its application and would re-submit its filing for the combined use of Tafinlar, also known as dabrafenib, and Mekinist, or trametinib, once it had additional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.

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