Axitinib
| Evidence Level: L5 | Predicted Indications: 4 |
Table of Contents
- Axitinib
- Pharmacist Assessment Report
- Axitinib: Tyrosine kinase inhibitor (VEGFR-targeting) → liposarcoma
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- India Market Information
- Cytotoxicity
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Axitinib: Tyrosine kinase inhibitor (VEGFR-targeting) → liposarcoma
One-Sentence Summary
Axitinib is an oral kinase inhibitor with a marketed presence in India under 14 valid licences. The TxGNN model predicts it may be effective for liposarcoma, but the supporting evidence is thin: no clinical trials and 1 preclinical publication are currently available.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | liposarcoma |
| TxGNN Prediction Score | 0.9987 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (14 of 14) – CDSCO approval status is not included in this data |
| Number of Listed Products | 14 (valid: 14) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Axitinib is generally known as a kinase inhibitor acting on the VEGFR/PDGFR pathways, which drive tumour blood-vessel formation.
A preclinical study (2016) reported that axitinib showed antiangiogenic and antitumour activity in myxoid liposarcoma cell lines. This offers a mechanistic rationale: liposarcoma is a soft-tissue sarcoma, and blocking angiogenesis could slow its growth.
However, that study addresses a subtype in laboratory models rather than liposarcoma in patients, and it provides no human data. The finding is hypothesis-generating only. Because no cited study directly tests liposarcoma in clinical settings, the evidence level is held at L5.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 27822137 | 2016 | Preclinical (in vitro/in vivo) | Sarcoma | Axitinib showed antiangiogenic and antitumour activity in myxoid liposarcoma cell lines, found while screening targeted and chemotherapy agents |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 187254 | Raxitinib 5mg Tablet | Bottle of 14 tablets | Not recorded |
| 6767 | Axzyb 1mg Tablet | Bottle of 60 tablets | Not recorded |
| 6404 | Axpero 1mg Tablet | Strip of 14 tablets | Not recorded |
| 31138 | Bdaxit 5mg Tablet | Strip of 14 tablets | Not recorded |
| 18543 | Axinib 1mg Tablet | Strip of 14 tablets | Not recorded |
14 valid licences are recorded, all for the single-ingredient drug; the five above are shown as examples.
Cytotoxicity
| Item | Content |
|---|---|
| Cytotoxicity Classification | Targeted therapy (kinase inhibitor) |
| 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: 100 interactions were found in the interaction query. Examples include:
- Major: Clarithromycin, Dexamethasone
- Moderate: Aprepitant, Clotrimazole, Miconazole, Naltrexone
- Minor: acid-reducing agents such as Famotidine, Ranitidine, Rabeprazole, Esomeprazole, Lansoprazole, Cimetidine, and antacids containing aluminium, calcium or magnesium
Please refer to the package insert for other safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is high, but the only support is one preclinical study in a myxoid liposarcoma model. No clinical trials or human data exist, so this remains a research question rather than a candidate ready for development.
To proceed, the following is needed:
- Clinical or well-designed translational data in liposarcoma patients, including the relevant subtypes
- Mechanism of action data to strengthen the mechanistic link
- Package insert warnings and contraindications, which are currently missing
- A review of the major interactions (e.g., clarithromycin, dexamethasone) for the intended patient population
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.