Cabozantinib

Evidence Level: L5

Predicted Indications: 5

Cabozantinib

Pharmacist Assessment Report

Cabozantinib: multikinase inhibitor (VEGFR2, MET, AXL) → liposarcoma

One-Sentence Summary

Cabozantinib is an oral multikinase inhibitor that blocks VEGFR2, MET and AXL, and it is marketed in India as single-ingredient tablets. The TxGNN model predicts it may be effective for liposarcoma, but the support is indirect: 1 clinical trial and 1 publication are listed, and both study soft tissue sarcoma in general rather than liposarcoma specifically.

Quick Overview

Item	Content
Original Indication	Not recorded in the local data
Predicted New Indication	liposarcoma
TxGNN Prediction Score	0.9983
Evidence Level	L5
India Market Status	Listed in a compiled Indian medicine price dataset (8 of 8) – CDSCO approval status is not included in this data
Number of Listed Products	8 (valid: 8)
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, cabozantinib inhibits VEGFR2, MET and AXL. These pathways are involved in tumour angiogenesis and progression, including in soft tissue sarcomas.

Liposarcoma is a soft tissue sarcoma, so activity in this group of tumours is biologically plausible. However, liposarcoma-specific data are limited. The listed studies cover mixed sarcoma subtypes, so they do not show that cabozantinib works in liposarcoma itself.

Because no listed study directly addresses liposarcoma, the evidence level is L5 (model prediction with no direct study), even though related sarcoma studies exist.

Clinical Trial Evidence

Trial Number	Phase	Status	Enrollment	Key Findings
NCT05836571	Phase 2	Active, not recruiting	66	Randomised trial of ipilimumab + nivolumab with or without cabozantinib in advanced soft tissue sarcoma. It is not liposarcoma-specific and has not reported results. The combination design makes it hard to isolate cabozantinib’s own contribution.

Literature Evidence

PMID	Year	Type	Journal	Key Findings
41770651	2026	Phase 1 trial	American Journal of Clinical Oncology	Evaluated the safety of neoadjuvant cabozantinib given with radiation therapy in extremity soft tissue sarcoma. Cabozantinib has shown activity in several sarcoma subtypes, and the study addressed concern about fistula or perforation with concurrent radiation.

India Market Information

Authorization Number	Product Name	Dosage Form	Approved Indication
38313	Cabolong Tablet	Bottle of 30 tablets	Not recorded
36242	Cabotib 40 Tablet	Bottle of 30 tablets	Not recorded
40996	Cabotib 20 Tablet	Bottle of 30 tablets	Not recorded
36088	Cabotres 20 Tablet	Bottle of 30 tablets	Not recorded
35518	Cabotres 40 Tablet	Bottle of 30 tablets	Not recorded

Cytotoxicity

Item	Content
Cytotoxicity Classification	Targeted therapy (multikinase 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: The data compiled for this report list 100 interactions, of which the first 20 are shown here. Major-level interactions include acetylsalicylic acid, cisapride, clarithromycin, dolasetron, granisetron and levofloxacin. Moderate-level interactions include loperamide, aprepitant, dexamethasone, bisacodyl and several laxatives (castor oil, glycerin, lactitol, lactulose, magnesium citrate). Fidaxomicin is Minor.
Other safety notes: A phase 1 study flagged concern about fistula or perforation when cabozantinib is combined with radiation therapy.

Please refer to the package insert for warnings and contraindications.

Conclusion and Next Steps

Decision: Hold

Rationale: The TxGNN score for liposarcoma is high (0.9983), but no listed study directly examines liposarcoma. The only supporting studies are in mixed soft tissue sarcoma, one of them a combination with checkpoint inhibitors.

To proceed, the following is needed:

Liposarcoma-specific clinical data, or sarcoma trials reporting results by subtype
Detailed mechanism of action data
Package insert warnings and contraindications from the India licence holders
A safety plan covering the interaction profile and the fistula/perforation risk seen with radiation
Disclaimer

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