Drug updated on 4/30/2024
| Dosage Form | Capsule (oral; 100 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.
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. | 2023 | GlaxoSmithKline., Research Triangle Park, NC |