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FDA restricted 2L maintenance indication for Zejula (niraparib) to only the patient population with deleterious or suspected deleterious gBRCAmut

  • GSK to restrict the second-line maintenance indication for Zejula (niraparib) to only the patient population with deleterious or suspected deleterious 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 OS analysis of the ENGOT-OV16/NOVA Ph 3 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. 

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