GSK receives positive opinion from European CHMP for pazopanib in the treatment of patients with certain advanced soft tissue sarcomas
GSK announced that the EMA CHMP has issued a positive opinion recommending marketing authorisation for Votrient for the treatment of adult patients with selective subtypes of advanced STS.
Issued: London UK
GlaxoSmithKline. plc (GSK) announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for Votrient® (pazopanib) for the treatment of adult patients with selective subtypes of advanced Soft Tissue Sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy. Efficacy and safety has only been established in certain STS histological tumour subtypes.
A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission, but does not always result in marketing authorisation.
As part of its assessment, the CHMP reviewed safety and efficacy data from clinical studies, including one randomised, double-blind, placebo controlled, multi-centre Phase III study.
Votrient is not approved or licensed in the EU for the treatment of advanced soft tissue sarcoma. For information about Votrient, including approved uses, please visit the Products section of this website for the E.U. Patient Information Leaflet and full U.S. Prescribing Information including BOXED WARNING for severe and fatal hepatotoxicity.
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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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.
