Votrient application to EMA for Ovarian Cancer withdrawn - Glaxo Smith Kline
Glaxo Smith Kline has announced that it has withdrawn its application to the European Medicines Agency (EMA) for a variation to the Marketing Authorisation for Votrient (pazopanib).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. 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.
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