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Home » FDA Approves GSK’s Zejula for Ovarian Cancer
FDA Approves GSK’s Zejula for Ovarian Cancer
The FDA approved GlaxoSmithKline’s Zejula (niraparib) as a maintenance treatment for women with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a response to platinum-based chemotherapy.
The approval was based on the results of a phase 3 trial of patients with newly diagnosed advanced ovarian cancer. Zejula significantly improved progression-free survival.
The agency approved the drug under its Real-Time Oncology Review Program, which is designed to streamline reviews of cancer treatments.
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