Drug updated on 5/17/2024
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.
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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. 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 Title | Year | Source |
---|---|---|
Zejula (niraparib) Prescribing Information. | 2023 | GlaxoSmithKline., Research Triangle Park, NC |