Drug updated on 3/28/2024
| Dosage Form | Capsule (oral: 100 mg) |
| Drug Class | Poly (ADP-ribose) polymerase (PARP) inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
- For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
- For the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with 3 or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability and who have progressed more than 6 months after response to the last platinum-based chemotherapy.
Summary
- 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.
- A total of 11 systematic reviews/meta-analyses were reviewed focusing on the use and effectiveness of Niraparib (Zejula) in treating ovarian cancer.
- The efficacy of PARP inhibitors including Niraparib (Zejula), Olaparib, and Rucaparib was comparable across studies with no significant difference noted among them when comparing outcomes such as progression-free survival and overall survival.
- Subgroup analyses suggested that these PARP inhibitors' effectiveness might not substantially differ based on BRCA mutation status; however, greatest benefit was seen in patients with BRCA mutations and homologous recombination-deficient tumors.
- In terms of safety profile comparison, Olaparib appeared to have a somewhat more favorable profile concerning grade 3 or higher adverse events compared to Niraparib (Zejula) which showed associations with higher incidences nausea, fatigue anemia etc., but individualized dosing regimen could reduce these effects without sacrificing efficacy.
- All three drugs -Nirparabid (Zeijla), Oliprabid, and Rucaprabin- share similar safety profiles although there are slight differences among them regarding spectrum grade 1-5 adverse events(AEs).
- Genetic testing plays an important role in personalized ovarian cancer treatment due its ability identify specific genetic backgrounds allowing for tailored therapeutic approaches using drugs like nirparabid (Zeijla).
- Nirparabid (Zeijla)'s oral administration route makes it viable home-treatment option especially during pandemic-related situations while also serving well as consolidation/maintenance therapy after platinum-based chemotherapy responses extending period patients can live without disease progression.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Zejula (Niraparib) Prescribing Information. | 2022 | 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 |
| PARP inhibitors in the management of ovarian cancer: ASCO guideline. | 2020 | Journal of Clinical Oncology |