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.