Fingolimod
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Fingolimod
- Fingolimod: From Relapsing-Remitting Multiple Sclerosis to Borderline Ovarian Serous Tumor
Fingolimod: From Relapsing-Remitting Multiple Sclerosis to Borderline Ovarian Serous Tumor
One-Sentence Summary
Fingolimod is an oral sphingosine-1-phosphate (S1P) receptor modulator, originally used to treat relapsing-remitting multiple sclerosis. The TxGNN model predicts it may be effective for borderline ovarian serous tumor, but the evidence is model prediction only, with no clinical trials and no publications linked to this indication. The only supporting material in the compiled data is a small body of preclinical cancer research (2 publications) attached to other, related ovarian predictions.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Relapsing-remitting multiple sclerosis (the Singapore licence texts are blank; this comes from the knowledge-graph indication data) |
| Predicted New Indication | Borderline ovarian serous tumor |
| TxGNN Prediction Score | 94.94% |
| 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 general knowledge, fingolimod is an S1P receptor modulator. It traps lymphocytes in lymphoid organs, which is how it reduces inflammatory attacks in multiple sclerosis.
S1P signalling has also been linked to the biology of ovarian epithelial tumours, which offers a possible, but unconfirmed, link to this prediction. The compiled data do not verify this link. Multiple sclerosis and ovarian tumours are also very different diseases, and the model score probably reflects proximity in the knowledge graph rather than a proven mechanism.
The other top-ranked predictions are almost all ovarian neoplasms (mostly benign), which suggests the model is picking up one broad "ovarian tumour" signal. Two preclinical studies are relevant to that wider theme:
- PMID 30120964 (2018): FTY720 (fingolimod) enhanced the anti-tumour activity of carboplatin and tamoxifen in a patient-derived xenograft model of ovarian cancer.
- PMID 30388910 (2019): fingolimod augmented pemetrexed killing of non-small cell lung cancer cells and ovarian cancer cells, and overcame resistance to ERBB inhibitors.
Both studies are preclinical. They suggest a chemosensitising effect in cancer models, not a direct effect on borderline serous tumours.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
No publications are linked to borderline ovarian serous tumor itself. The two preclinical publications below were linked to related ovarian predictions (serous neoplasm and ovarian benign neoplasm) and are shown as indirect context only.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 30120964 | 2018 | Preclinical (patient-derived xenograft) | Cancer Letters | FTY720 sensitised drug-resistant ovarian cancer cells and enhanced the anti-tumour activity of carboplatin and tamoxifen in a xenograft model |
| 30388910 | 2019 | Preclinical (cell and in vivo models, non-ovarian focus) | Cancer Biology & Therapy | Fingolimod synergised with pemetrexed to kill NSCLC and ovarian cancer cells and overcame resistance to ERBB inhibition |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN14153P | Gilenya Capsule 0.5mg | Capsule | Not stated in the licence data |
| SIN15761P | Gilenya Capsule 0.25mg | Capsule | Not stated in the licence data |
Both products are oral capsules made by Novartis, and both licences are valid.
Safety Considerations
The package insert warnings and contraindications were not available in the compiled data, so please refer to the package insert for the official safety information.
Supplementary information from other sources:
- Possible disease-related contraindications (knowledge-graph data, not label text): liver failure, kidney disease, diabetes mellitus and diabetic ketoacidosis, lung disease, leukopenia, uveitis and other eye inflammation, macular oedema (retinal and cystoid), atrioventricular block, and sick sinus syndrome. These should be confirmed against the official label.
- Drug interactions: 100 interactions were identified; the 20 reviewed include these.
- Major: systemic and ophthalmic corticosteroids (hydrocortisone, prednisone, dexamethasone, betamethasone, budesonide, triamcinolone), clarithromycin, levofloxacin, ondansetron, dolasetron, palonosetron, and cisapride.
- Moderate: famotidine, ranitidine, cimetidine, nizatidine, loperamide, and naltrexone.
- Minor: metronidazole.
Fingolimod lowers circulating lymphocytes, which is a concern for any population with immune or haematological vulnerability.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on a model score alone (L5), with no trials and no publications for borderline ovarian serous tumor. The only related data are preclinical chemosensitisation studies, which are indirect. A systemic immunomodulator with cardiac, ocular and infection-related risks is hard to justify for a low-grade or borderline tumour without supporting data.
To proceed, the following is needed:
- Mechanism of action data, and an analysis of whether S1P signalling is actually relevant to borderline serous tumours
- Preclinical studies in models of borderline or low-grade serous ovarian tumours
- Package insert warnings and contraindications from the HSA, so the safety screen can be completed
- A risk-benefit assessment for this patient group, covering lymphopenia, cardiac conduction, and macular oedema
- A check of the related predictions (such as serous neoplasm), where the preclinical evidence is stronger, as possible research questions
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.