News >

FDA Grants Priority Review to Niraparib for Late-Stage Ovarian Cancer

Gina Columbus @ginacolumbusonc
Published: Monday, Jun 24, 2019

Mary Lynne Hedley

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.

... to read the full story
To Read the Full Story

View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Publication Bottom Border
Border Publication
x