Zejula as First-line Treatment for Advanced Ovarian Cancer Before FDA

Zejula as First-line Treatment for Advanced Ovarian Cancer Before FDA
The U.S. Food and Drug Administration (FDA) has accepted GSK's request to extend approval for Zejula (niraparib) to include as a first-line maintenance therapy for women with newly diagnosed and advanced ovarian cancer who responded to platinum-based chemotherapy, regardless of mutations in DNA repair genes. The application, made in the form of a supplemental New Drug Application (sNDA), is being reviewed under the Real-Time Oncology Review (RTOR) pilot program, set to speed up the review process and ensure that safe treatments are available as soon as possible, GSK announced in a press release. Zejula is an oral, once-daily PARP inhibitor. It works by preventing the activity of PARP enzymes, which are involved in DNA repair. Interfering with the ability of cancer cells to repair DNA can kill these cells. Zejula is currently approved in the United States and 
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