Regulatory update: Votrient® (pazopanib) as maintenance therapy for advanced ovarian cancer in the EU
Issued: London UK
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that it has withdrawn its application to the European Medicines Agency (EMA) for a variation to the Marketing Authorisation for Votrient® (pazopanib). This application, made in August 2013, was related to the additional indication for the maintenance treatment of women with FIGO stage II-IV epithelial ovarian, fallopian tube or primary peritoneal cancer who had not progressed after receiving first-line chemotherapy.
GSK has taken the decision because the data from the planned second interim Overall Survival (OS) analysis of the phase III study did not support the overall benefit:risk for Votrient in this indication. The hazard ratio for OS was 1.076 (p=0.4985; 95% CI: 0.868; 1.333).These data will be submitted for presentation at an upcoming medical congress. GSK does not intend to progress further with this indication in other countries.
“There is significant unmet need in the treatment of advanced ovarian cancer”, said Dr Rafael Amado, Head of Oncology R&D at GSK.
“We believe that, in spite of the improvement in progression free survival observed in our Phase III study, the totality of the evidence including these more mature OS data, do not support an overall positive benefit-risk for Votrient in this indication. While we are disappointed by these results, we will progress additional analyses which may add to the body of scientific evidence in this disease setting.”
The regulatory submission for Votrient in this indication was based on the results from AGO-OVAR-16 (VEG110655), a randomised, double-blind, phase III, placebo-controlled study which evaluated the efficacy and safety of pazopanib monotherapy as compared with placebo in women with FIGO stage II-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease had not progressed after first-line chemotherapy.
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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. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2013.