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
Price :
$35
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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
- 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.