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A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer

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Trial Profile

A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Apr 2023

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At a glance

  • Drugs Niraparib (Primary)
  • Indications Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms NOVA
  • Sponsors TESARO
  • Most Recent Events

    • 11 Nov 2022 According to a GlaxoSmithKline media release, based on the FDA review of the final overall survival (OS) analysis of the trial, the company has decided to restrict the second-line maintenance indication for Zejula (niraparib) to only the patient population with deleterious or suspected deleterious germline BRCA mutations (gBRCAmut).
    • 22 Sep 2022 According to a GlaxoSmithKline media release, updated final overall survival data was recently shared with the FDA.
    • 22 Sep 2022 Results published in the GlaxoSmithKline Media Release.
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