Axitinib
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Axitinib: From Renal Cell Carcinoma to Renal Cell Carcinoma Associated with Neuroblastoma
One-Sentence Summary
Axitinib is an oral VEGFR-targeted kinase inhibitor, originally used to treat advanced renal cell carcinoma (RCC). The TxGNN model predicts it may be effective for renal cell carcinoma associated with neuroblastoma. However, 0 clinical trials and 0 publications were found for this specific condition, so the prediction is not yet supported by independent evidence.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Renal cell carcinoma (including clear cell and non-papillary subtypes) |
| Predicted New Indication | Renal cell carcinoma associated with neuroblastoma |
| TxGNN Prediction Score | 99.90% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 2 |
| 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, axitinib is a selective inhibitor of vascular endothelial growth factor receptors 1, 2 and 3 (VEGFR-1/2/3). Its efficacy in RCC is well established, and mechanistically it may be applicable to other kidney tumours that depend on tumour blood vessel growth.
The Singapore licence text for axitinib does not state an approved indication. The original indication above therefore comes from the TxGNN knowledge graph. The prediction most likely arises because this condition sits close to RCC in the knowledge graph. No trials or publications were found for this specific entity, so there is no independent mechanistic or clinical support for it. The relationship between the original and predicted indication should be treated as a statistical association, not a demonstrated pharmacological link.
For context, other predicted indications in the same analysis have more support. Two examples are TFE3-translocation RCC, with a randomised Phase 2 trial of axitinib plus nivolumab (NCT03595124, n=15), and collecting duct carcinoma, with a Phase 2 trial of checkpoint inhibitors plus axitinib (NCT06211114, n=30). Neither has results yet.
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 |
|---|---|---|
| SIN14321P | INLYTA TABLETS 1MG | Film-coated tablet (oral) |
| SIN14322P | INLYTA TABLETS 5MG | Film-coated tablet (oral) |
Both licences are valid single-ingredient products manufactured by Pfizer Manufacturing Deutschland GmbH.
Cytotoxicity
| Item | Content |
|---|---|
| Cytotoxicity Classification | Targeted therapy (VEGFR tyrosine kinase inhibitor), not a conventional cytotoxic agent |
| Myelosuppression Risk | Please refer to the package insert warnings and precautions |
| Emetogenicity Classification | Please refer to the package insert warnings and precautions |
| Monitoring Items | Please refer to the package insert warnings and precautions |
| Handling Protection | Please refer to the package insert warnings and precautions |
Safety Considerations
- Drug Interactions: The data compiled for this report records 100 interactions; the first 20 are summarised here.
- Major: clarithromycin, dexamethasone
- Moderate: aprepitant, clotrimazole, miconazole, naltrexone
- Minor: acid-reducing agents and antacids, including famotidine, ranitidine, cimetidine, nizatidine, rabeprazole, esomeprazole, lansoprazole, dexlansoprazole, aluminium hydroxide, calcium carbonate, magaldrate, and magnesium carbonate, hydroxide and oxide
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is very high (99.90%), but it has no supporting trials or literature, which corresponds to evidence level L5. The condition is rare, and the prediction probably reflects proximity to RCC in the knowledge graph. Axitinib's established benefit in RCC cannot be assumed to carry over to this specific entity.
To proceed, the following is needed:
- Clinical or case-level evidence in this specific condition, and confirmation that it is a distinct, clinically meaningful entity
- Detailed mechanism of action data for axitinib
- The Singapore package insert, to confirm the approved indication, warnings and contraindications
- A decision on whether to prioritise better-supported predictions from the same analysis, such as TFE3-translocation RCC or collecting duct carcinoma
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.