Niraparib

(Zejula®)

Niraparib

Drug updated on 10/30/2024

Dosage FormTablet (oral; 100 mg, 200 mg, 300 mg)
Drug ClassPoly (ADP-ribose) polymerase (PARP) inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy
  • Indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy
  • Select patients for therapy based on an FDA-approved companion diagnostic for ZEJULA.

Latest News

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Summary
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  • This summary is based on the review of 13 systematic review(s)/meta-analysis(es). [1-13]
  • PARP inhibitors, including niraparib, significantly improved progression-free survival (PFS) compared to placebo in both recurrent and newly diagnosed ovarian cancer populations, with hazard ratios (HR) ranging from 0.24 to 0.50 across genetic subgroups such as BRCA mutant, germline BRCA mutant, and BRCA wild-type populations.
  • Niraparib plus bevacizumab showed the highest inferred PFS benefits in the intention-to-treat (SUCRA 96.7) and HRD (SUCRA 98.4) populations, highlighting its effectiveness in these subgroups.
  • No significant differences in overall survival (OS) were observed between PARP inhibitors and placebo groups. Additionally, no significant PFS differences were found among olaparib, niraparib, and rucaparib in various subgroups, including BRCA mutant, HRD, and overall populations.
  • Niraparib monotherapy showed a specific PFS improvement over chemotherapy in BRCA mutant recurrent ovarian cancer (HR 0.62), while combination therapies like niraparib plus bevacizumab demonstrated superior PFS benefits in certain subgroups.
  • Niraparib was associated with a higher risk of grade 3 or 4 adverse events, including anemia, thrombocytopenia, neutropenia, and fatigue, compared to placebo. Additionally, 19.87% of patients experienced grade 3 or 4 hypertension.
  • Niraparib had a higher incidence of severe adverse events (thrombocytopenia, neutropenia) compared to other PARP inhibitors like olaparib and rucaparib, with olaparib showing fewer grade 3 or higher adverse events.
  • Individualized dosing of niraparib led to fewer adverse effects and reduced discontinuation rates compared to the standard dosing, improving its safety profile while maintaining efficacy.
  • BRCA mutant, HRD, and overall populations consistently benefited from PARP inhibitors, particularly niraparib, with significant PFS improvements observed across these subgroups. No significant differences in PFS were found among PARP inhibitors in BRCA mutant and HRD populations, and treatment effect did not vary based on age, prior chemotherapy response, or prior bevacizumab use.

Product Monograph / Prescribing Information

Document TitleYearSource
Zejula (niraparib) Prescribing Information.2024GlaxoSmithKline., Research Triangle Park, NC

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Past and present: a bibliometric study on the treatment of recurrent ovarian cancer2024Frontiers in Pharmacology
PARP inhibitor era in ovarian cancer treatment: a systematic review and meta-analysis of randomized controlled trials2024Journal of Ovarian Research
Arterial hypertension associated with PARPi: A meta-analysis of 41 placebo randomized controlled trials combined with a World Health Organization's pharmacovigilance study2024Fundamental & Clinical Pharmacology
The impact of PARP inhibitors in the whole scenario of ovarian cancer management: A systematic review and network meta-analysis2024Critical Reviews in Oncology/Hematology
Incidence and risk of hypertension associated with PARP inhibitors in cancer patients: a systematic review and meta-analysis2023BMC Cancer
The Molecular Mechanisms of Actions, Effects, and Clinical Implications of PARP Inhibitors in Epithelial Ovarian Cancers: A Systematic Review2022International Journal of Molecular Sciences
Comparative Efficacy and Safety of Poly (ADP-Ribose) Polymerase Inhibitors in Patients With Ovarian Cancer: A Systematic Review and Network Meta-Analysis2022Frontiers in Oncology
Safety Profile of Niraparib as Maintenance Therapy for Ovarian Cancer: A Systematic Review and Meta-Analysis2022Current Oncology (Toronto, Ont.)
Comparative safety and tolerability of approved PARP inhibitors in cancer: A systematic review and network meta-analysis2021Pharmacological Research
Molecular and clinical predictors of improvement in progression-free survival with maintenance PARP inhibitor therapy in women with platinum-sensitive, recurrent ovarian cancer: A meta-analysis2021Cancer
Comparative Efficacy and Safety of PARP Inhibitors as Maintenance Therapy in Platinum Sensitive Recurrent Ovarian Cancer: A Network Meta-Analysis2020Frontiers in Oncology
Comparison of Poly (ADP-ribose) Polymerase Inhibitors (PARPis) as Maintenance Therapy for Platinum-Sensitive Ovarian Cancer: Systematic Review and Network Meta-Analysis2020Cancers
Evaluation of the Efficacy and Safety of PARP Inhibitors in Advanced-Stage Epithelial Ovarian Cancer2020Frontiers in Oncology

Clinical Practice Guidelines