Erdafitinib
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Erdafitinib: From Its Registered Use to Pulmonary Hypertension
One-Sentence Summary
Erdafitinib is an oral FGFR (fibroblast growth factor receptor) kinase inhibitor, currently marketed in Singapore as Balversa film-coated tablets. The TxGNN model predicts it may be effective for pulmonary hypertension, but at present there are 0 clinical trials and 0 publications specific to this prediction, so it is a model prediction only.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the available licence records |
| Predicted New Indication | Pulmonary hypertension |
| TxGNN Prediction Score | 99.38% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 3 |
| 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 pharmacology, erdafitinib is a pan-FGFR (FGFR1-4) tyrosine kinase inhibitor.
FGFR signalling, particularly FGFR1, has been implicated in pulmonary vascular remodelling and the proliferation of pulmonary artery smooth muscle cells. This gives a plausible but unproven rationale for the prediction. However, FGFR inhibition may also carry vascular and cardiac toxicity concerns (for example, effects on endothelial integrity), so the direction of effect is uncertain.
The high TxGNN score (0.994) is a computational prediction only. No supporting trials or literature were found. The original indication could not be confirmed from the licence records, so the link between the original and new indications cannot be assessed.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available for pulmonary hypertension.
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN15986P | BALVERSA FILM-COATED TABLETS 3MG | Tablet, film coated | Not stated in licence record |
| SIN15987P | BALVERSA FILM-COATED TABLETS 4MG | Tablet, film coated | Not stated in licence record |
| SIN15988P | BALVERSA FILM-COATED TABLETS 5MG | Tablet, film coated | Not stated in licence record |
All three licences are valid, held by Janssen Cilag SpA, and are for the oral route.
Cytotoxicity
| Item | Content |
|---|---|
| Cytotoxicity Classification | Targeted therapy (kinase inhibitor, FGFR1-4) |
| 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 interaction screen returned 100 potential interactions; 20 are listed in the data compiled for this report, and the interaction severity levels are recorded below.
- Major: cholecalciferol, calcitriol, calcifediol, dexamethasone, clarithromycin, calcium phosphate, calcium acetate, magnesium oxide, magnesium sulfate, magnesium chloride
- Moderate: metformin, loperamide, saxagliptin, linagliptin, empagliflozin, eliglustat, naldemedine, naloxegol, prucalopride, rifaximin
- Other points from the mechanism review: FGFR inhibition may affect vascular and cardiac function, and is associated with hyperphosphatemia and other endocrine or metabolic effects. Several of the major interactions (vitamin D analogues, calcium and magnesium salts) may be relevant to this phosphate-related effect.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on a model score alone (Evidence Level L5), with no clinical trials or literature for pulmonary hypertension. The mechanistic rationale is plausible but unproven, and FGFR inhibition raises vascular and cardiac safety concerns. Package insert safety data and the original indication are also missing.
To proceed, the following is needed:
- Package insert warnings and contraindications from the HSA (this blocks safety screening)
- Approved indication text and mechanism of action data
- Preclinical evidence (for example, pulmonary hypertension models) showing the direction of FGFR inhibition effect
- A cardiovascular and pulmonary vascular safety assessment
- A literature and trial search specific to erdafitinib in pulmonary hypertension
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.