Skip to Content Skip to Search

Regulatory Update - GSK announces EU submission seeking additional indication for Votrient® as maintenance therapy for advanced ovarian cancer

GSK today announced submission to the European Medicines Agency of a variation to the Marketing Authorisation for Votrient® (pazopanib)

Issued: London UK

GlaxoSmithKline (GSK) plc today announced submission to the European Medicines Agency of a variation to the Marketing Authorisation for Votrient® (pazopanib), adding the additional indication for the maintenance treatment of women with Stage II-IV ovarian, fallopian tube or primary peritoneal cancer who have not progressed after receiving first-line chemotherapy.

“This EU filing, the third for pazopanib in less than five years, confirms GSK’s commitment to deliver our oncology pipeline. We are currently working on submission plans for other countries throughout the world.” said Dr. Rafael Amado, Head of Oncology R&D, GlaxoSmithKline.

Pazopanib is not approved or licensed anywhere in the world for the maintenance treatment of ovarian, fallopian tube or primary peritoneal cancer. For the EU SPC for the approved indications for pazopanib, please visit: http://health.gsk.com/. For full US Prescribing Information including BOXED WARNING for hepatoxocity please visit http://us.gsk.com/en-us/products/prescription-medicines-and-vaccines/

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:

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)


Cautionary statement regarding forward-looking statements
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 Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.