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.
