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GlaxoSmithKline: FDA Approves SNDA For Zejula - Quick Facts

GlaxoSmithKline plc (GSK,GSK.L) announced the US FDA approved the company's supplemental New Drug Application for Zejula (niraparib), a poly polymerase inhibitor, as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status.

Hal Barron, President R&D, GSK, said: "Women with advanced ovarian cancer have a five-year survival rate of less than 50%. This expanded indication means that many more women with this devastating disease can receive earlier treatment with Zejula, which can extend the time it takes for their cancer to progress."

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