Reuters: Regulatory News: GSK submits melanoma drugs in U.S., Europe

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GSK submits melanoma drugs in U.S., Europe Aug 3rd 2012, 09:32 LONDON | Fri Aug 3, 2012 5:32am EDT LONDON Aug 3 (Reuters) - GlaxoSmithKline said on Friday said it had submitted two skin cancer drugs, each designed to block different pathways used by tumour cells, for approval in Europe and the United States. The British pharmaceutical company said in June the drugs, Dabrafenib and Trametinib, beat chemotherapy in late-stage trials. It said it had submitted an application in Europe for Dabrafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation, and had submitted both drugs in the United States for the same patient group. "These regulatory submissions represent important progress in our oncology pipeline." said Rafael Amado, GSK's head of oncology R&D. It said it planned to submit an application to the European Medicines Agency for Trametinib in the coming months."

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