Axitinib

Evidence Level: L4

Predicted Indications: 4

Axitinib

Pharmacist Assessment Report

Axitinib: VEGFR tyrosine kinase inhibitor → liposarcoma

One-Sentence Summary

Axitinib is an oral tyrosine kinase inhibitor that blocks VEGF receptors and is marketed in Australia as Inlyta tablets. The TxGNN model predicts it may be useful for liposarcoma. Support is limited to 1 preclinical publication and no registered clinical trials.

Quick Overview

Item	Content
Original Indication	Not recorded in the local data
Predicted New Indication	liposarcoma
TxGNN Prediction Score	0.9987
Evidence Level	L4
Australia Market Status	Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data
Number of PBS Items	1 (valid: 1)
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 known as an inhibitor of vascular endothelial growth factor receptors (VEGFR), which drive tumour angiogenesis. Blocking this pathway is the basis for its use in other solid tumours.

Liposarcoma is a soft-tissue sarcoma, and some subtypes depend on new blood vessel growth. A preclinical study reported that axitinib had antiangiogenic and antitumorigenic activity in myxoid liposarcoma cell models. This is consistent with its VEGFR-inhibiting action. However, this evidence comes from laboratory work only. No human efficacy data were found, and the similarity between the drug’s established use and this prediction has not been formally assessed.

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 antitumorigenic activity in myxoid liposarcoma cell lines, identified in a screen of targeted and chemotherapy agents.

Australia Market Information

ARTG Number	Product Name	Dosage Form	Approved Indication
ARTG 10539Q	Inlyta	Tablet 1 mg	Not recorded in the local data

Cytotoxicity

Item	Content
Cytotoxicity Classification	Targeted therapy (tyrosine kinase inhibitor)
Myelosuppression Risk	Please refer to the Product Information (PI) warnings and precautions
Emetogenicity Classification	Please refer to the Product Information (PI) warnings and precautions
Monitoring Items	Please refer to the Product Information (PI) warnings and precautions
Handling Protection	Please refer to the Product Information (PI) warnings and precautions

Safety Considerations

Please refer to the TGA-approved Product Information (PI) for warnings and contraindications.

Drug Interactions (100 interactions recorded; selected higher-severity examples):

Major: clarithromycin, dexamethasone
Moderate: aprepitant, clotrimazole, miconazole, naltrexone
Minor: acid-reducing agents such as famotidine, ranitidine, cimetidine, proton pump inhibitors (rabeprazole, esomeprazole, lansoprazole, dexlansoprazole) and antacids (aluminium, calcium and magnesium salts)

Conclusion and Next Steps

Decision: Hold

Rationale: The only supporting evidence is a single preclinical study in myxoid liposarcoma cell models, with no clinical trials and no human efficacy data. A high model score alone does not justify moving forward.

To proceed, the following is needed:

Clinical or in vivo efficacy data in liposarcoma, including specific subtypes
Mechanism of action data to support the mechanistic link
Safety information from the TGA-approved Product Information, including warnings and contraindications
Review of the major drug interactions (clarithromycin, dexamethasone) relevant to a sarcoma treatment setting
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.