Niraparib gets priority review for ovarian cancerAugust 6, 2019
Niraparib (Zejula) has been granted priority review by the US FDA for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients.
The niraparib sNDA is supported by data from the QUADRA trial.
QUADRA is a large multicentre, open-label, single-arm, phase 2 study that evaluated the safety and activity of niraparib in adult patients with relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who were treated with three or more previous chemotherapy regimens.
Patients received oral niraparib 300 mg once daily continuously until disease progression.
The primary objective was the proportion of patients achieving an investigator-assessed confirmed overall response in patients with homologous recombination deficiency (HRD)-positive tumours (including patients with BRCA and without BRCA mutations) sensitive to their last platinum-based therapy.