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GSK Stock Inches Higher on Accelerated FDA Approval

Results from a trial received a priority FDA review


GlaxoSmithKline (GSK) says that federal regulators had cleared a combination of its drugs to treat melanoma, sending GSK stock modestly higher in Thursday morning trading.

prescription pills in bottles
Source: iStockphoto

GSK indicated that Mekinist had been approved for use in combination with Tafinlar to combat unresectable melanoma and metastatic melanoma  by the U.S. Food and Drug Administration (FDA). For metastatic melanoma, the drug combination has been approved only in patients who posses specific gene mutations that must be identified through an FDA-approved screening process.

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The drugs received accelerated approval from the FDA after the results of a clinical trial were were granted a priority review.

A randomized Phase II showed the two drugs produced an overall response rate among patients of 76%. Patients who only received one drug had an overall response rate of just 54%.

In November, the FDA relaxed restrictions it imposed on GSK’s once best-selling diabetes drug Avandia back in 2010 after researchers raised safety concerns.

GSK stock has climbed about 18% since March. Since mid-October, GSK stock has fluctuated between $50 a share and just under $53 a share.

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