Hal Barron, MD
Niraparib (Zejula) as a maintenance treatment demonstrated a statistically significant improvement in progression-free survival (PFS) compared with placebo in patients with ovarian cancer following first-line platinum-based chemotherapy, regardless of biomarker status, meeting the primary endpoint of the phase III PRIMA (ENGOT-OV26/GOG-3012) trial.1
Under the Prescription Drug User Fee Act, the FDA must make a decision on the application by October 24, 2019.
- GSK announces positive headline results in Phase 3 PRIMA study of ZEJULA (niraparib) for patients with ovarian cancer in the first line maintenance setting. GlaxoSmithKline. Published July 15, 2019. https://bit.ly/2YTFO6h. Accessed July 15, 2019.
- U.S. Food and Drug Administration accepts GSK’s application for ZEJULA (niraparib) in late stage ovarian cancer with priority review. GlaxoSmithKline. Published June 24, 2019. https://bit.ly/2Le2Alq. Accessed June 24, 2019.
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