FDA Grants Priority Review to GSK’s Zejula for Late Stage Ovarian Cancer

FDA Grants Priority Review to GSK’s Zejula for Late Stage Ovarian Cancer
The U.S. Food and Drug Administration (FDA) has accepted the application of Tesaro, a GSK company, seeking to extend approval for Zejula (niraparib) to women with late stage ovarian cancer who have received three or more prior chemotherapy treatments.  The potentially new indication will cover advanced ovarian, fallopian tube, or primary peritoneal cancer patients. It would treat women whose cancer either has a BRCA mutation, or a mutation in other DNA repair genes (causing homologous recombination deficiency, HRD), and whose disease has progressed more than six months after the last platinum-based chemotherapy. The supplemental New Drug Application (sNDA) — given priority review, with a decision expected by Oct. 24 — was su
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