Mekinist

Treatment for Melanoma - Metastatic

Update: Mekinist (trametinib) Now FDA Approved - May 29, 2013

Regulatory Update: Trametinib US PDUFA Date Extended to 3 September 2013

GSK today announced that the US Prescription Drug User Fee Act (PDUFA) goal date for trametinib, its MEK inhibitor, has been extended by 3 months to 3 September 2013.  The company recently submitted additional manufacturing data to the Food and Drug Administration (FDA) and the extension to the original PDUFA goal date is to allow sufficient time for FDA to review the submission.

On 3 August 2012, GSK announced submission of a New Drug Application for trametinib as a treatment for patients with unresectable or metastatic melanoma with BRAF V600 mutations as detected by an FDA-approved test.

On 7 February 2013, GSK announced submission of a Marketing Authorisation Application to the European Medicines Agency (EMA) for trametinib monotherapy and in combination with dabrafenib as a treatment for patients with unresectable or metastatic melanoma with BRAF V600 mutations.  The new manufacturing information submitted to FDA will also be shared with the EMA according to the standard centralised review process.

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)

 David Daley
 +44 (0) 20 8047 5502
 (London)

 Catherine Hartley
 +44 (0) 20 8047 5502
 (London)

US Media enquiries:
 Stephen Rea
 +1 215 751 4394
 (Philadelphia)

 Kevin Colgan
 +1 919 483 2933
 (North Carolina)

 Melinda Stubbee
 +1 919 483 2510
 (North Carolina)

 Mary Anne Rhyne
 +1 919 483 0492
 (North Carolina)

 Sarah Alspach
 +1 202 715 1048
 (Washington, DC)

 Jennifer Armstrong
 +1 215 751 5664
 (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: May 2013

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Mekinist (trametinib) FDA Approval History

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