GSK files Votrient at EMA for Ovarian Cancer
GlaxoSmithKline (GSK)has announced submission to the European Medicines Agency of a variation to the Marketing Authorisation for Votrient (pazopanib), adding the additional indication for the maintenance treatment of women with Stage II-IV Ovarian, Fallopian Tube or Primary Peritoneal Cancer who have not progressed after receiving first-line chemotherapy.
Pazopanib is not approved or licensed anywhere in the world for the maintenance treatment of ovarian, fallopian tube or primary peritoneal cancer.
The latest filing is based on the Phase III study (NCT00866697). This compared pazopanib monotherapy with placebo in women with epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease had not progressed after completing standard debulking surgery and first-line chemotherapy. The study met the primary objective of a statistically significant improvement in progression-free survival (PFS) compared with placebo, reducing the risk by 23% (HR=0.77; 95% CI: 0.64-0.91; p=0.0021). The median PFS in the pazopanib group was 17.9 months compared with 12.3 months for placebo. However, there was a higher incidence of serious adverse events in the pazopanib group (26% vs 11%).
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