Glaxo's Melanoma Drug Gets FDA Priority Review

GSK Receives Priority Review From FDA for Dabrafenib/Trametinib Combination in Metastatic Melanoma

LONDON, Sept. 16, 2013 - GlaxoSmithKline plc (LSE:GSK) today announced that the US Food and Drug Administration (FDA) has granted Priority Review designation to its supplemental New Drug Applications (sNDAs) for combined use of Tafinlar® (dabrafenib) and Mekinist® (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 E or K mutation.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of 8 January 2014 for the Mekinist® (trametinib) supplement and 9 January 2014 for the Tafinlar® (dabrafenib) supplement.

The applications are based on data from a randomised Phase I/II study comparing combination therapy with dabrafenib and trametinib to dabrafenib monotherapy in adult patients with BRAF V600E and V600K mutation positive metastatic melanoma.

Use of dabrafenib and trametinib in combination is investigational and not approved anywhere in the world. On 7 February 2013, GSK announced European regulatory submission for the combined use of dabrafenib and trametinib adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation and the review is ongoing according to standard timelines.

For full US Prescribing Information and Medication Guide and EU Patient Information Leaflet or Summary of Product Characteristics (SPC) for Tafinlar® and Mekinist®, please visit http://www.gsk.com/products/index.htm.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

GlaxoSmithKline Enquiries:

UK Media enquiries:

 David Mawdsley

 +44 (0) 20 8047 5502

 (London)

 Simon Steel

 +44 (0) 20 8047 5502

 (London)

 David Daley

 +44 (0) 20 8047 5502

 (London)

 Catherine Hartley

 +44 (0) 20 8047 5502

 (London)

US Media enquiries:

 Melinda Stubbee

 +1 919 483 2510

 (North Carolina)

 Stephen Rea

 +1 215 751 4394

 (Philadelphia)

 Bernadette King

 +1 215 751 3632

 (Philadelphia)

 Anna Padula

 +1 215 751 4271

 (Philadelphia)

Analyst/Investor enquiries:

 Ziba Shamsi

 + 44 (0) 20 8047 3289

 (London)

 Lucy Budd

 +44 (0) 20 8047 2248

 (London)

 Tom Curry

 + 1 215 751 5419

 (Philadelphia)

 Gary Davies

 + 44 (0) 20 8047 5503

 (London)

 James Dodwell

 + 44 (0) 20 8047 2406

 (London)

 Jeff McLaughlin

 + 1 215 751 7002

 (Philadelphia)
 

Posted: September 2013

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