Lenvatinib

Evidence Level: L3

Predicted Indications: 5

Lenvatinib

Pharmacist Assessment Report

Lenvatinib: Liposarcoma

One-Sentence Summary

Lenvatinib is an oral multi-kinase inhibitor (VEGFR, FGFR, PDGFRα, KIT, RET), and the approved indication is not recorded in the local data. The TxGNN model predicts it may be effective for liposarcoma. Evidence consists of 1 clinical trial (a single-arm Phase Ib/II study) and 4 publications, which gives an overall evidence level of L3.

Quick Overview

Item	Content
Original Indication	Not recorded in the local data
Predicted New Indication	Liposarcoma
TxGNN Prediction Score	0.9951
Evidence Level	L3
India Market Status	Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data
Number of Listed Products	at least 20
Recommended Decision	Hold

Why is This Prediction Reasonable?

Lenvatinib blocks several receptor tyrosine kinases: VEGFR1-3, FGFR1-4, PDGFRα, KIT and RET. These receptors drive tumour blood-vessel growth and growth-factor signalling, and both processes also matter in soft tissue sarcomas. Cutting off these signals could slow tumour growth in liposarcoma.

The most direct support is the LEADER study, which combined lenvatinib with eribulin. Eribulin is a microtubule inhibitor with a different, complementary mechanism, so the two drugs may add to each other’s antitumour activity. Preclinical work also points to possible synergy with agents acting on CDK4, which is amplified in well-differentiated and dedifferentiated liposarcoma.

The evidence is limited. The only clinical study is single-arm and small, and there is no randomized comparison. The benefit of lenvatinib alone in liposarcoma remains untested.

Clinical Trial Evidence

Trial Number	Phase	Status	Enrollment	Key Findings
NCT03526679	Phase 1/Phase 2	Completed	30	Single-arm LEADER study of lenvatinib plus eribulin in inoperable or metastatic adipocytic sarcoma and leiomyosarcoma, testing safety and efficacy (2018-07 to 2025-10)

Literature Evidence

PMID	Year	Type	Journal	Key Findings
36129471	2022	Phase Ib/II single-arm trial	Clin Cancer Res	Published LEADER study results on the safety and efficacy of lenvatinib plus eribulin in advanced liposarcoma and leiomyosarcoma, where treatment options are limited
39103896	2024	Preclinical / biomarker study	Exp Hematol Oncol	CDK4 as a prognostic biomarker in soft tissue sarcoma; synergy when CDK4 inhibition is used in sequential treatment of dedifferentiated liposarcoma
29848686	2018	Preclinical study	Anticancer Res	Eribulin, used in liposarcoma, showed broad antitumour activity in xenograft models and in combination with agents of differing mechanisms
34326745	2021	Case report	Case Rep Oncol	Marked tumour shrinkage in a patient with dedifferentiated liposarcoma and lung metastasis given individualized targeted, surgical and chemotherapy treatment

India Market Information

Lenvatinib is marketed in India as single-ingredient products, with 20 valid licences and none cancelled. The approved indication text is not recorded in the local data. The records below are partial, and only the main ones are listed.

Authorization Number	Product Name	Dosage Form	Approved Indication
121256	Lenvima 4mg Capsule (Eisai Pharmaceuticals India)	Strip of 10 capsules	Not stated in licence record
121303	Lenvatol 4mg Capsule (Cipla)	Strip of 10 capsules	Not stated in licence record
121908	Lenvatol 10mg Capsule (Cipla)	Strip of 10 capsules	Not stated in licence record
96241	Glenvas 4mg Capsule (Glenmark)	Strip of 10 capsules	Not stated in licence record
124324	Lenvanib 4mg Tablet (AMPS Biotech)	Strip of 10 tablets	Not stated in licence record

Cytotoxicity

Item	Content
Cytotoxicity Classification	Targeted therapy (multi-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; at minimum, the blood count and liver and renal function are usually monitored. In the combination with eribulin, monitor the combination’s own toxicity.
Handling Protection	Follow institutional handling rules for antineoplastic oral agents

Safety Considerations

Drug Interactions: 260 interactions are recorded in total. Two are rated Major: dolasetron and cisapride. Most others are rated Moderate, including famotidine, loperamide, bisacodyl, clarithromycin, levofloxacin, palonosetron, granisetron, naltrexone, and several laxatives and bowel-preparation agents (picosulfuric acid, polyethylene glycol, sodium sulfate, castor oil, glycerin, lactitol, lactulose, magnesium citrate, magnesium hydroxide). Metronidazole is rated Minor.

Package-insert warnings and contraindications could not be obtained for this report. Please refer to the package insert for complete safety information.

Conclusion and Next Steps

Decision: Hold

Rationale: The evidence level is L3. The only direct clinical evidence is one small, single-arm Phase Ib/II study of lenvatinib plus eribulin (NCT03526679; PMID 36129471), with no randomized trial. Package-insert safety data are also missing. The prediction is plausible and worth further research, but it is not yet strong enough for a development decision.

To proceed, the following is needed:

Randomized or at least larger controlled studies in liposarcoma, including the contribution of lenvatinib versus eribulin alone
Detailed mechanism of action data
Package-insert warnings and contraindications, and a safety monitoring plan, particularly for the combination with eribulin
Review of the Major interactions (dolasetron, cisapride) and the Moderate ones in the 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.