FDA Approves PARP Inhibitor Niraparib in Recurrent Ovarian Cancer
The FDA approved Zejula (niraparib), developed by Tesaro, as a maintenance treatment for recurrent ovarian, fallopian tube or peritoneal cancers
The approval was based on a Phase III trial comparing Zejula to placebo in over 550 patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who had received at least two prior treatments of platinum-based chemotherapy within the previous eight weeks, and were in a complete or partial response.
Patients were split between two cohorts based on BRCA mutations. The trial demonstrated improvements in progression-free survival with Zejula regardless of cohort, with median PFS for those with a BRCA mutation reaching 21 months compared to 5.5 months with placebo. In patients without a BRCA mutation, median PFS was 9.3 months compared to 3.9 months. The approval does not require the use of a companion diagnostic test.