GSK provides an update on Zejula US prescribing information for Ovarian Cancer.
GSK plc has provided an update that at the request of the FDA it will restrict the second-line maintenance indication for Zejula (niraparib) to only the patient population with deleterious or suspected deleterious germline BRCA mutations (gBRCAmut)
The US first-line indication of Zejula remains unchanged for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy.
This decision follows an FDA review of the final overall survival (OS) analysis of the ENGOT-OV16/NOVA phase III trial, which served as the basis for the approval of the second-line maintenance indication. In the final OS results from the NOVA trial, the secondary endpoint of OS demonstrated a hazard ratio (HR) of 1.06 (95% CI: 0.81-1.37) in the non-gBRCAmut cohort.
NOVA is a randomised, double-blind, placebo-controlled phase III trial of niraparib, an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor for the maintenance treatment of women with platinum-sensitive recurrent ovarian cancer. The primary endpoint of the NOVA study was progression-free survival (PFS), evaluated as two independently powered cohorts (gBRCAmut and non-gBRCAmut); results demonstrated the clinically meaningful and statistically significant benefit of niraparib in both cohorts and across the HRD subgroups in the non-gBRCAmut cohort. Secondary endpoints were safety and long-term exploratory endpoints, including overall survival. GSK is in ongoing discussions about these and other emerging OS data with health authorities worldwide.
150 mins
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.