Niraparib

(Zejula®)

Zejula®

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Drug updated on 5/17/2024

Dosage FormCapsule (oral; 100 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.

Summary
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  • Niraparib (Zejula) is 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. It's also used for treating those with deleterious or suspected deleterious germline BRCA-mutated recurrent versions of these cancers.
  • The information was derived from 10 systematic reviews and meta-analyses on niraparib (Zejula).
  • Compared to other poly (ADP-ribose) polymerase (PARP) inhibitors such as olaparib and rucaparib, niraparib has shown significant efficacy in improving progression-free survival for patients with both recurrent and newly diagnosed ovarian cancers across all populations, including BRCA mutant cases.
  • In terms of safety profile, while all PARP inhibitors come with an increased risk of adverse events, niraparib is associated specifically with higher risks of hematological toxicities like anemia, thrombocytopenia, and neutropenia. However, these side effects can be managed through dose adjustments.
  • Benefits from using niraparib were observed irrespective of the patient’s BRCA mutation status, indicating its broader application potential. A study showed that tumors which are BRCA wild-type / homologous recombination repair deficient might benefit more from this therapy.
  • During the COVID-19 pandemic, it was found that home-based treatment regimens using PARP inhibitors, including niraparib, have been effective in managing tumors due to their convenient administration route.

Product Monograph / Prescribing Information

Document TitleYearSource
Zejula (niraparib) Prescribing Information.2023GlaxoSmithKline., Research Triangle Park, NC

Systematic Reviews / Meta-Analyses

Document TitleYearSource
PARP inhibitor era in ovarian cancer treatment: a systematic review and meta-analysis of randomized controlled trials.2024Journal of Ovarian Research
Homologous recombination deficiency testing to inform patient decisions about niraparib maintenance therapy for high-grade serous or endometrioid epithelial ovarian cancer: a health technology assessment.2023Ontario Health Technology Assessment Series
The molecular mechanisms of actions, effects, and clinical implications of parp inhibitors in epithelial ovarian cancers: a systematic review.2022International Journal of Molecular Science
Comparative efficacy and safety of poly (ADP-ribose) polymerase inhibitors in patients with ovarian cancer: a systematic review and network meta-analysis.2022Frontiers in Oncology
Safety profile of niraparib as maintenance therapy for ovarian cancer: a systematic review and meta-analysis.2022Current Oncology
Comparison of the efficacy and safety of parp inhibitors as a monotherapy for platinum-sensitive recurrent ovarian cancer: a network meta-analysis.2021Frontiers in Oncology
Comparative safety and tolerability of approved PARP inhibitors in cancer: a systematic review and network meta-analysis. 2021Pharmacological Research
Poly (ADP-ribose) polymerase inhibitors in solid tumours: systematic review and meta-analysis.2021European Journal of Cancer
Consolidation or maintenance systemic therapy for newly diagnosed stage II, III, or IV epithelial ovary, fallopian tube, or primary peritoneal carcinoma: a systematic review.2021Critical Reviews in Oncology/ Hematology
Comparison of poly (ADP-ribose) polymerase inhibitors (PARPis) as maintenance therapy for platinum-sensitive ovarian cancer: systematic review and network meta-analysis. 2020Cancers
Evaluation of the efficacy and safety of PARP inhibitors in advanced-stage epithelial ovarian cancer.2020Frontiers in Oncology

Clinical Practice Guidelines