Vinblastine
| Evidence Level: L3 | Predicted Indications: 10 |
Table of Contents
Vinblastine: From Hodgkin Lymphoma to Rhabdomyosarcoma
One-Sentence Summary
Vinblastine is a vinca alkaloid historically used to treat Hodgkin lymphoma, testicular cancer, and other malignancies, though it currently holds no marketing authorization in India. The TxGNN model predicts it may be effective for Rhabdomyosarcoma, with 0 clinical trials directly testing vinblastine and 16 publications (mostly case reports and preclinical studies) currently supporting this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not locally registered (globally used for Hodgkin lymphoma, testicular cancer, and other malignancies as part of combination chemotherapy) |
| Predicted New Indication | Rhabdomyosarcoma (disease) |
| TxGNN Prediction Score | 99.86% |
| Evidence Level | L3 |
| India Market Status | Not Marketed |
| Number of Registrations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not currently available in the evidence pack (data gap DG002). Based on established pharmacology, vinblastine is a vinca alkaloid that binds tubulin and inhibits microtubule polymerization, arresting cells in mitosis (M-phase) — a class effect shared with vincristine and vinorelbine.
Rhabdomyosarcoma (RMS) is a pediatric soft-tissue sarcoma for which the standard-of-care VAC regimen (vincristine, actinomycin-D, cyclophosphamide) already relies on a vinca alkaloid. This creates strong mechanistic plausibility for vinblastine: the closely related agent vinorelbine has demonstrated activity in Phase II pediatric sarcoma trials, and individual case reports document vinblastine-containing combination regimens producing partial responses in perianal and prostatic RMS.
However, evidence for vinblastine specifically (as opposed to its vinca-alkaloid relatives vincristine/vinorelbine) remains limited to small case reports, xenograft models, and decades-old case series. No completed clinical trial has tested vinblastine directly in RMS, which is why the evidence level is capped at L3 despite the very high TxGNN prediction score.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 38050209 | 2023 | Case report | Medicine | Adult perianal RMS with nodal metastases achieved partial response after nivolumab, dacarbazine, cisplatin, and vinblastine following progression on prior therapy |
| 2451411 | 1987 | Case report/review | Hinyokika Kiyo | Refractory prostatic RMS in a child; cisplatin + vinblastine + peplomycin (PVP) rapidly reduced pelvic tumor mass after relapse |
| 3329524 | 1987 | Preclinical mechanistic | Anti-Cancer Drug Design | Examined therapeutic selectivity of vinca alkaloids (vincristine/vinblastine) using human RMS xenograft models in mice |
| 22633624 | 2012 | Phase II trial (vinorelbine, related agent) | Eur J Cancer | Vinorelbine + low-dose cyclophosphamide showed efficacy and good tolerance in relapsed/refractory pediatric RMS |
| 15378498 | 2004 | Pilot study (vinorelbine, related agent) | Cancer | Pilot study defining optimal vinorelbine + low-dose cyclophosphamide dosing ahead of European RMS protocol |
| 12115359 | 2002 | Clinical study (vinorelbine, related agent) | Cancer | Vinorelbine showed activity in previously treated advanced pediatric sarcomas including RMS |
| 22156656 | 2011 | Pilot study | Oncotarget | Metronomic 4-drug pediatric regimen explored as alternative strategy against resistant sarcomas |
| 26024389 | 2015 | In vitro mechanistic | Cell Death Differ | PLK1 inhibitors synergize with microtubule-destabilizing drugs (vinca-alkaloid class) in preclinical RMS models |
| 16302215 | 2007 | Case series (related sarcoma) | Pediatr Blood Cancer | Vinorelbine/low-dose cyclophosphamide regimen (developed for RMS) showed response in desmoplastic small round cell tumor |
| 41216926 | 2026 | Prospective trial (non-RMS soft tissue sarcoma) | Pediatr Blood Cancer | CWS-96/CWS-2002P trials establish risk stratification and chemotherapy regimens for non-RMS soft tissue sarcomas, providing regimen context |
India Market Information
Vinblastine currently holds no marketing authorization in India — market status is “Not Marketed” with 0 registered licenses on file. No product registration data is available to summarize.
Cytotoxicity
Based on established pharmacological classification (DrugBank-level data not available in this evidence pack; DG002):
| Item | Content |
|---|---|
| Cytotoxicity Classification | Conventional cytotoxic (Vinca alkaloid / microtubule inhibitor class) |
| Myelosuppression Risk | High — neutropenia is the primary dose-limiting toxicity of vinblastine |
| Emetogenicity Classification | Low to Moderate |
| Monitoring Items | CBC with differential (before each dose), liver function tests, assessment for peripheral neuropathy, extravasation site monitoring (vesicant) |
| Handling Protection | Required — vinblastine is a hazardous/cytotoxic agent and a vesicant; standard cytotoxic drug handling precautions apply. As a well-established class safety fact, vinca alkaloids including vinblastine are fatal if administered intrathecally — this is not sourced from local label data (which is a blocking data gap, DG001) and must be confirmed against the official package insert once available. |
Safety Considerations
- Drug Interactions: 371 total interactions on file. Notable examples include a Major interaction with Clarithromycin, and Moderate interactions with Aprepitant, Dexamethasone, Metronidazole, Eliglustat, Miconazole, Rolapitant, Rosuvastatin, Simvastatin, Tinidazole, Glycerol phenylbutyrate, and Troglitazone. A Minor interaction is noted with Levofloxacin.
Key warnings and contraindications are not available in the current evidence pack (data gap DG001, Blocking severity) — please refer to the official package insert once obtained.
Conclusion and Next Steps
Decision: Hold
Rationale: Evidence supporting vinblastine specifically (not just the vinca-alkaloid class) in rhabdomyosarcoma is limited to case reports, xenograft studies, and decades-old case series — no completed trial has tested vinblastine directly in this indication. Combined with the drug’s complete absence from the India market (0 registrations) and a blocking data gap on local safety labeling, the evidence does not yet support proceeding.
To proceed, the following is needed:
- TFDA-equivalent package insert / local label data (warnings, contraindications) — DG001, Blocking
- Confirmed mechanism of action documentation via DrugBank — DG002
- A direct clinical study (even Phase I/II) evaluating vinblastine — not just related vinca alkaloids — in RMS
- A pathway for market authorization in India if this indication is pursued further
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.