FDA restricts indication for GSK's Zejula

UK pharma major GSK’s (LSE: GSK) shares closed down 6% at 1,323.60 pence on Friday, as it said that it would only recommend its ovarian-cancer treatment Zejula (niraparib) as a secondary maintenance treatment to a subgroup of patients in the US who carry a specific genetic mutation connected to breast cancer, known as BRCA.

GSK noted that the US first-line indication of Zejula, a PARP indhibitor, 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 a US Food and Drug Administration (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.