- 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.
- Also Read: GSK's Conditionally Approved Blood Cancer Drug Fails On Progression-Free Survival Goal Over Standard Care.
- 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.
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