Drug updated on 12/11/2024
Dosage Form | Tablet (oral; 100 mg, 200 mg, 300 mg) |
Drug Class | Poly (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
Summary
- This summary is based on the review of 13 systematic review(s)/meta-analysis(es). [1-13]
- Polymerase (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 BReast CAncer gene (BRCA) mutant, germline BRCA mutant, and BRCA wild-type populations.
- Niraparib plus bevacizumab showed the highest inferred PFS benefits in the intention-to-treat (the surface under the cumulative ranking (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, homologous recombination deficiency (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 Title | Year | Source |
---|---|---|
Zejula (niraparib) Prescribing Information. | 2024 | GlaxoSmithKline., Research Triangle Park, NC |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
An Ontario Health (Cancer Care Ontario) Clinical Practice Guideline: Consolidation or Maintenance Systemic Therapy for Newly Diagnosed Stage II, III, or IV Epithelial Ovary, Fallopian Tube, or Primary Peritoneal Carcinoma | 2021 | Current Oncology (Toronto, Ont.) |
PARP Inhibitors in the Management of Ovarian Cancer: ASCO Guideline | 2020 | Journal of Clinical Oncology |