GSK withdraws European marketing authorization for ovarian cancer drug Votrient

UK pharma major GlaxoSmithKline (LSE: GSK) has withdrawn its application to the European Medicines Agency for a variation to the Marketing Authorization for Votrient (pazopanib) related to the additional indication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 to withdraw the application, made in August 2013, 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. These data will be submitted for presentation at an upcoming medical congress but GSK does not intend to progress further with this indication in other countries. In 2013 Votrient sales grew 80% to £331 million ($551 million).

Rafael Amado, head of oncology R&D at GSK, said: “There is significant unmet need in the treatment of advanced ovarian cancer. 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.”