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 supported by results of the QUADRA  Phase 2 trial (NCT02354586). Zejula demonstrated relevant activity not only in patients with BRCA mutations, but also in women with heavily pretreated ovarian cancer without such mutations. “The results of the QUADRA study demonstrate that Zejula is active as a late-line treatment for patients beyond those with BRCA mutations. With this study, we continue to advance our mission to provide more patients with ovarian cancer an opportunity to benefit from treatment with Zejula,” Mary Lynne Hedley, PhD, president and CEO of Tesaro, said in a press release. Zejula is currently approved in the U.S. and Europe as a maintenance therapy in women who have had a recurrence of high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer, but who have completely or partially responded to platinum-based chemotherapy. The medicine, which is taken as a once-daily pill, can be used in women with or without germline, or inherited, mutations in BRCA1 or BRCA2 genes. Zejula belongs to th
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