Mekinist
Generic name: trametinib
Treatment for: Melanoma, Metastatic, Non Small Cell Lung Cancer, Thyroid Cancer, Solid Tumors, Low-Grade Glioma
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
Related articles
- Novartis Combination Targeted Therapy Tafinlar + Mekinist Receives FDA Approval for BRAF V600E Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC) - June 22, 2017
- GSK Gains Accelerated FDA Approval for Combination Use of Mekinist (trametinib) and Tafinlar (dabrafenib) - January 9, 2014
- FDA Approves Mekinist (trametinib) for Advanced Melanoma - May 29, 2013
Mekinist (trametinib) FDA Approval History
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.