Skip to Content Skip to Search

Regulatory update – GSK announces submissions in the EU and US for dabrafenib and trametinib

GlaxoSmithKline (GSK) plc today announced regulatory submissions in the European Union and United States (US) related to single-agent use of its BRAF inhibitor dabrafenib and MEK inhibitor trametinib to treat patients with BRAF V600 mutation positive metastatic melanoma.

Issued: London, UK

GlaxoSmithKline (GSK) plc today announced regulatory submissions in the European Union and United States (US) related to single-agent use of its BRAF inhibitor dabrafenib and MEK inhibitor trametinib to treat patients with BRAF V600 mutation positive metastatic melanoma, specifically:

  • A Marketing Authorisation Application to the European Medicines Agency for dabrafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
  • A New Drug Application to the US Food and Drug Administration for dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation as detected by an FDA-approved test.
  • A New Drug Application to the US Food and Drug Administration for trametinib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutations as detected by an FDA-approved test.

“These regulatory submissions represent important progress in our Oncology pipeline.” said Dr. Rafael Amado, Head of Oncology R&D at GSK “We are planning to submit an application to the European Medicines Agency for trametinib in BRAF V600 mutation positive metastatic melanoma in the coming months.”

GSK entered a collaboration with bioMérieux (aworld leader in in vitro diagnostics,bioMérieux) in 2010 to develop a molecular theranostic test to detect BRAF V600 (V600E and V600K) gene mutations found in several cancers, including melanoma. bioMérieux has filed for FDA Pre-Market Approval of the test and it is currently being utilised in the Phase III trametinib-dabrafenib combination programme to identify appropriate patients.

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)

 

Stephen Rea

+44 (0) 20 8047 5502

(London)

 

Sarah Spencer

+44 (0) 20 8047 5502

(London)

 

David Daley

+44 (0) 20 8047 5502

(London)

 

 

 

 

US Media enquiries:

Robert Perry

+1 215 751 7583

(Philadelphia)

 

Melinda Stubbee

+1 919 483 2510

(North Carolina)

 

     

Analyst/Investor enquiries:

Sally Ferguson

+44 (0) 20 8047 5543

(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)

 

Ziba Shamsi

+ 44 (0) 20 8047 3289

(London)

GlaxoSmithKline cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk factors' in the 'Financial review & risk' section in the company's Annual Report 2011 included as exhibit 15.2 to the company's Annual Report on Form 20-F for 2011.