LONDON (Alliance News) - Pharma giant GlaxoSmithKline PLC said Monday that the US Food and Drug Administration (FDA) had granted priority review status to applications made for combined use of two of its drugs in the treatment of melanoma.
The two drugs, Mekinist (trametinib) and Tafinlar (dabrafenib), are not currently approved for use together anywhere in the world. Use of them in combination is described as "investigational", but GSK said that the supplemental New Drug Applications it had submitted were based on the result of a randomised phase I/II study which compared the effectiveness of the drugs in treating adult patients with metastatic melanoma to treatment using dabrafenib alone.
Earlier this year GSK announced that it had submitted the combined use of the drugs to treat certain patients to European regulators. The review is ongoing, according to standard timelines, the company said.
Shares in Glaxo were trading at 1,630.68 pence Monday morning, up 8.68p.
By Philip Nye; philipnye@alliancenews.com
Copyright 2013 Alliance News Limited. All Rights Reserved.
Glaxosmithkline (GSK)