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Home Industry News GlaxoSmithKline receives US priority review status for melanoma therapy

GlaxoSmithKline receives US priority review status for melanoma therapy

17th September 2013

GlaxoSmithKline has been granted priority review designation by the US Food and Drug Administration (FDA) for a promising new treatment for metastatic melanoma.

The regulator will accelerate the review process for the combined use of Tafinlar (dabrafenib) and Mekinist (trametinib) among adult patients with unresectable or metastatic melanoma with a BRAF V600 E or K mutation.

A randomised phase I/II study comparing this new combination therapy with dabrafenib monotherapy among patients in this group suggested that the new treatment approach could be beneficial in numerous ways.

Currently, this combination is not approved anywhere in the world, but the FDA's decision will increase optimism over its chances of receiving approval in Europe, where a regulatory submission for the new therapy regimen was submitted in February 2013.

This comes in the same month that the European Commission ratified GlaxoSmithKline's drug Tafinlar as a monotherapy for unresectable or metastatic melanoma in adult patients with a BRAF V600 mutation.ADNFCR-8000103-ID-801638223-ADNFCR

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