Mary Lynne Hedley, PhD
The FDA has granted a priority review designation to a supplemental biologics license application for niraparib (Zejula) for the treatment of patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with ≥3 or more prior chemotherapy regimens, and who have either a BRCA
mutation or have homologous recombination deficiency (HRD) and progressed >6 months after their last platinum-based chemotherapy.1
The designation is based on findings from the QUADRA study, in which the overall response rate (ORR) was 28% (95% CI, 15.6-42.6; P
= .00053) in the primary efficacy population of patients who had HRD and who received at least 3 prior lines of therapy.2
Under the Prescription Drug User Fee Act, the FDA must make a decision on the application by October 24, 2019, according to a press release from GlaxoSmithKline, which has acquired Tesaro, the developer of niraparib.
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