Niraparib
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Niraparib: From Ovarian and Peritoneal Cancer to Epiglottis Neoplasm
One-Sentence Summary
Niraparib is an oral PARP inhibitor, originally used for ovarian and primary peritoneal cancers. The TxGNN model predicts it may be effective for Epiglottis Neoplasm, but no clinical trials and no publications currently support this specific prediction. It rests on the model's graph-based prediction alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Malignant epithelial tumour of ovary; peritoneal cancer, including primary peritoneal carcinoma and serous/papillary carcinoma; desmoplastic small round cell tumour |
| Predicted New Indication | Epiglottis neoplasm |
| TxGNN Prediction Score | 99.99% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 4 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on known information, niraparib inhibits the DNA-repair enzymes PARP1 and PARP2. It works mainly through synthetic lethality in tumours with homologous recombination deficiency (HRD), such as BRCA-mutated tumours. Its efficacy in ovarian and peritoneal serous cancers is established, and mechanistically it could apply to other tumours that share this DNA-repair weakness.
For epiglottis neoplasm, however, no direct link has been established. The high TxGNN score is a graph-based prediction only. The data contain no HRD or BRCA information for epiglottic tumours, and no studies or case reports connect PARP inhibition to this disease. The prediction should therefore be treated as a hypothesis, not as supported evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Singapore Market Information
| Authorization Number | Product Name | Dosage Form |
|---|---|---|
| SIN16460P | ZEJULA Film-Coated Tablet 200mg | Film-coated tablet |
| SIN16459P | ZEJULA Film-Coated Tablet 100mg | Film-coated tablet |
| SIN17109P | Akeega Film-coated Tablets 50mg/500mg | Film-coated tablet |
| SIN17110P | Akeega Film-coated Tablets 100mg/500mg | Film-coated tablet |
All four registrations are valid and oral. The approved indication text was not available in the registration records compiled for this report.
Cytotoxicity
| Item | Content |
|---|---|
| Cytotoxicity Classification | Targeted therapy (PARP inhibitor) |
| Myelosuppression Risk | Hematologic toxicity is a recognised concern for this drug. Please refer to the package insert warnings and precautions for grading. |
| Emetogenicity Classification | Please refer to the package insert warnings and precautions |
| Monitoring Items | Complete blood count at minimum. Please refer to the package insert for the full monitoring schedule. |
| Handling Protection | Please refer to the package insert and local cytotoxic or hazardous drug handling regulations |
Safety Considerations
- Drug Interactions: The interaction screening returned 100 interacting drugs in total, and the first 20 are summarised here.
- Major: Deferiprone and samarium (153Sm) lexidronam.
- Moderate (mostly additive bleeding or myelosuppression concerns):
- Antithrombotic and antiplatelet agents: acetylsalicylic acid, abciximab, alteplase, antithrombin III, apixaban, betrixaban, bivalirudin, cangrelor, caplacizumab, cilostazol, dipyridamole.
- Radiopharmaceuticals: iobenguane (I-131), ibritumomab tiuxetan, tositumomab (with and without I-131), strontium chloride Sr-89.
- Others: rolapitant, palifermin.
Label-based warnings and contraindications were not available for this report. Please refer to the package insert for complete safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: This prediction has no registered trials and no literature, and no mechanistic evidence links PARP inhibition to epiglottis neoplasm. Under the evidence rules it is L5, model prediction only.
For context, the second-ranked prediction, cystic neoplasm, has a different evidence profile. It maps mainly to ovarian and endometrial serous carcinomas and has a recruiting Phase 2 trial of niraparib in endometrial serous carcinoma (NCT04716686), plus supportive HRD-guided PARP inhibitor literature. It was assessed as L2 and is a better candidate for further evaluation.
To proceed, the following is needed:
- Tumour biology data for epiglottic neoplasms, such as HRD or BRCA status and other DNA-repair gene alterations
- Preclinical or early clinical evidence of PARP inhibitor activity in this tumour type
- Detailed mechanism of action data (MOA)
- Package insert warnings and contraindications, so a safety screen can be completed
- A review of the predicted disease's histology, since benign or non-specific categories would not justify systemic oncology treatment
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.