On March 31, 2014 GlaxoSmithKline reported that it has withdrawn its application to the European Medicines Agency (EMA) for a variation to the Marketing Authorisation for Votrient (pazopanib) (Press release GlaxoSmithKline, MAR 31, 2014, View Source;votrient—pazopanib–as-maintenance-therapy-.html [SID:1234500354]). 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 (NCT01227928) 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.
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.