Eribulin
| Evidence Level: L2 | Predicted Indications: 10 |
Table of Contents
Eribulin: From Soft-Tissue Sarcoma to Fibroblastic Neoplasm (Solitary Fibrous Tumor)
One-Sentence Summary
Eribulin is a microtubule dynamics inhibitor already used as later-line chemotherapy for unresectable or metastatic soft-tissue sarcoma. The TxGNN model, together with a completed Phase 2 trial and eight supporting publications, points to Fibroblastic Neoplasm (including solitary fibrous tumor and the fibrosarcoma/myxofibrosarcoma spectrum) as the most credible new-indication signal in this evidence pack. Nine other TxGNN-ranked candidates in this pack (including the single highest-scoring one, familial Mediterranean fever) were screened but held back — they carry no clinical or literature support and, in several cases, no plausible mechanistic link — so this report focuses on the one candidate with an actual evidence base.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Soft-tissue sarcoma (second-line/salvage chemotherapy — per literature evidence in this pack, e.g. PMID 39197933); no formal TFDA/EU authorization record is present in this pack |
| Predicted New Indication | Fibroblastic Neoplasm (solitary fibrous tumor / fibrosarcoma spectrum) |
| TxGNN Prediction Score | 99.36% (rank 6,653 of all drug–disease pairs) |
| Evidence Level | L2 |
| EU Market Status | Not marketed |
| Number of Authorizations | 0 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed structured mechanism-of-action data is not available for eribulin in this evidence pack (marked as a data gap, DG002). Based on information embedded in the collected literature and trial evidence, eribulin is an anti-tubulin (microtubule dynamics) inhibitor that is already used clinically as chemotherapy for unresectable or metastatic soft-tissue sarcoma. This existing anti-sarcoma activity is mechanistically the most direct bridge to the new indication.
Fibroblastic neoplasm is a category of mesenchymal tumors — solitary fibrous tumor, fibrosarcoma, myxofibrosarcoma — that sit squarely within the sarcoma family eribulin already treats. This is not a mechanistic leap across unrelated biology (unlike several other candidates in this pack, see below); it is an extension within the same tumor lineage the drug is already active against.
That mechanistic plausibility is reinforced by actual data: a completed, prospective Phase 2 trial (ERASING, Italian Sarcoma Group) tested eribulin specifically in advanced solitary fibrous tumor, and multiple preclinical studies show eribulin activity (including combination/resensitization strategies) against fibrosarcoma and myxofibrosarcoma cell models. This is a materially stronger basis than the other nine candidates in this pack, several of which (e.g., familial Mediterranean fever, pleural adenomatoid tumor) have no mechanistic rationale connecting an autoinflammatory or typically benign condition to a cytotoxic antimitotic agent, and none of which have any trial or literature support at all (L5, Hold).
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT03840772 | Phase 2 | Completed | 16 | ERASING study (Italian Sarcoma Group): eribulin in advanced solitary fibrous tumor, a representative fibroblastic neoplasm subtype |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 38136399 | 2023 | Review | Cancers | Diagnostic and treatment overview of extrameningeal solitary fibrous tumors, an intermediate/malignant mesenchymal neoplasm class |
| 28284173 | 2017 | Cohort | European Journal of Cancer | Patient-derived solitary fibrous tumor xenografts show high sensitivity to doxorubicin/dacarbazine (confirmed clinically) and highlight potential effectiveness of trabectedin or eribulin |
| 39197933 | 2024 | Review | Anticancer Research | Recombinant methioninase increases eribulin efficacy 16-fold in highly eribulin-resistant HT1080 fibrosarcoma cells, addressing acquired drug resistance in soft-tissue sarcoma |
| 38423656 | 2024 | Review | Anticancer Research | Synergy between recombinant methioninase and eribulin against fibrosarcoma cells in vitro, sparing normal fibroblasts |
| 40295012 | 2025 | Review | In Vivo | Super-eribulin-resistant HT1080 fibrosarcoma cells become more malignant but are synergistically arrested by eribulin plus methionine restriction in nude mice |
| 39625530 | 2024 | Review | Human Cell | Establishment of a novel myxofibrosarcoma cell line (SMU-MFS) for studying and developing new therapies in this fibroblastic neoplasm |
| 34383271 | 2021 | Review | Human Cell | Establishment of a patient-derived myxofibrosarcoma cell line (NCC-MFS4-C1) to support development of new treatments |
| 35906852 | 2023 | Review | Genes, Chromosomes & Cancer | Case report of a malignant peripheral nerve sheath tumor (a related fibroblastic/mesenchymal neoplasm) responding to entrectinib via an NTRK fusion; supportive of the broader fibroblastic-neoplasm treatment landscape but not eribulin-specific |
EU Market Information
Eribulin currently has no marketing authorization recorded in this evidence pack (market status: not marketed; 0 authorizations), so no EU license table can be produced.
Cytotoxicity
| Item | Content |
|---|---|
| Cytotoxicity Classification | Conventional cytotoxic (microtubule dynamics/anti-tubulin inhibitor) |
| Myelosuppression Risk | Please refer to the SmPC warnings and precautions |
| Emetogenicity Classification | Please refer to the SmPC warnings and precautions |
| Monitoring Items | CBC with differential, liver and renal function |
| Handling Protection | Cytotoxic drug handling precautions apply |
Safety Considerations
Please refer to the SmPC for safety information. (This pack flags TFDA label warnings/contraindications as a Blocking data gap — DG001 — meaning no drug-specific safety evaluation can be completed until that data is obtained.)
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: One completed Phase 2 trial (ERASING, n=16) directly targeting solitary fibrous tumor, backed by multiple preclinical studies on fibrosarcoma/myxofibrosarcoma, gives this candidate L2 evidence and a mechanistically coherent rationale (eribulin’s established anti-sarcoma activity extending to a related mesenchymal tumor family). This is meaningfully stronger than the other nine candidates in the pack, all of which are L5/Hold with no supporting trials or literature.
To proceed, the following is needed:
- TFDA/EMA product label warnings and contraindications (Blocking gap, DG001) — required before any safety (S1) evaluation
- Detailed mechanism-of-action pharmacology data (DG002)
- Confirmation of route/dosage-form compatibility for the fibroblastic neoplasm population (currently marked “pending”)
- A larger confirmatory trial beyond the single n=16 Phase 2 study
- Drug-drug interaction data (current DDI query returned no results)
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.