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.
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