GSK receives positive opinion from European CHMP for pazopanib

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 Votrient – Prescription medicines – Our products – GlaxoSmithKline for the E.U. Patient Information Leaflet and full U.S. Prescribing Information including BOXED WARNING for severe and fatal hepatotoxicity.