Patients with advanced ovarian cancer will be disappointed by news that GlaxoSmithKline has withdrawn its application to market Votrient (pazopanib) in Europe for certain types of the disease.
The drug giant was seeking to expand Votrient's label to include 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.
But the file was pulled after a disappointing analysis of data from a Phase III trial failed to support an overall benefit-risk profile for these patients, despite earlier findings that the drug improved progression free survival.
"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," said Rafael Amado, Head of Oncology R&D at GSK.
Votrient is approved in Europe for the treatment of advanced kidney cancer and certain forms of soft tissue sarcoma.