GSK Limits Second-Line Maintenance Use Of Its Ovarian Cancer Drug To Some Populations

GSK plc GSK would restrict the second-line maintenance indication for Zejula to only patients with harmful, or suspected to be harmful, inherited BRCA mutations at the request of the FDA.
The decision follows an FDA review of the final overall survival (OS) analysis of the ENGOT-OV16/NOVA phase 3 trial, which served as the basis for the approval of the second-line maintenance indication.
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In the final OS results from the NOVA trial, the secondary endpoint of OS demonstrated a hazard ratio (HR) of 1.06 in the non-gBRCAmut cohort.
Zejula's U.S. indication for earlier lines of treatment as a first maintenance option in adults in some types of advanced ovarian, fallopian tube, or primary peritoneal cancer patients responding to chemotherapy remains unchanged, GSK said.
Price Action: GSK shares are down 4.33% at $32.02 during the premarket session on the last check Friday.