Overview
Vinflunine is a third-generation member of the vinca alkaloid family with anti-tumour actions. It was first described in 1998 at the Pierre Fabre research center in France. Like other vinca agents, vinflunine is an anti-mitotic agent that induces a cell cycle arrest at the G2/M phase and promotes cell death via apoptosis . Vinflunine is a microtubule inhibitor that binds to tubulin at or near to the vinca binding sites to inhibits its polymerization into microtubules during cell proliferation . In murine tumors and human tumor xenografts, vinflunine exhibits an antitumor efficacy than Vinorelbine, Vinblastine, and Vincristine . Having an incidence of 429,700 new cases per year worldwide, urothelial carcinoma of the bladder is one of the most common malignancies that mostly affects individuals aged 50–79 years . Some patients with advanced urothelial carcinoma experience inadequate therapeutic response from a prior platinum-containing regimen. While these patients have a median survival of approximately 4 months and a poor prognosis , there is currently no standard therapy in patients with advanced urothelial carcinoma . In 2009, vinflunine was approved by the European Medicines Agency (EMA) as a second-line therapy of metastatic and advanced urothelial cancer after failure of platinum-based treatment . Vinflunine ditartrate is an active ingredient in the EMA-authorised product Javlor for intravenous infusion. Efficacy and safety of vinflunine has not been studied in patients with performance status of 2 or less. The clinical use of vinflunine in other urologic malignancies, such as inoperable cancer of the penis, are currently have been investigated .
Indication
For use as a monotherapy in adults with advanced or transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing therapy .
Associated Conditions
- Transitional Cell Carcinoma of the Urothelial Tract
- Metastatic Transitional Cell Carcinoma of the Urothelial Tract
Research Report
Comprehensive Monograph: Vinflunine (Javlor®)
Executive Summary
Vinflunine is a third-generation, fluorinated vinca alkaloid that represents an incremental but important evolution in its therapeutic class. Its primary clinical value is established by its European Medicines Agency (EMA) approval as a second-line monotherapy for advanced or metastatic urothelial carcinoma after the failure of platinum-based chemotherapy, a clinical niche now significantly challenged by the advent of newer immunotherapies and antibody-drug conjugates (ADCs). The unique pharmacological profile of vinflunine, characterized by a distinct and weaker interaction with tubulin, may confer a more favorable neurotoxicity profile compared to its predecessors. This potential safety advantage is counterbalanced by a modest survival benefit and a significant, though manageable, safety burden dominated by myelosuppression and constipation. The divergent regulatory decisions by the EMA, which granted approval, and the United States Food and Drug Administration (FDA), which did not, underscore the fine balance of its risk-benefit profile in a rapidly evolving oncology landscape.
Key characteristics of vinflunine include:
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2020/08/27 | Phase 3 | Completed | |||
2018/03/22 | Phase 3 | Active, not recruiting | |||
2018/01/04 | Phase 3 | Active, not recruiting | |||
2016/07/27 | Phase 1 | Withdrawn | Ligartis GmbH | ||
2016/01/27 | Phase 2 | Completed | Dr Anders Ullén | ||
2015/01/27 | Phase 3 | Completed | |||
2014/11/27 | Phase 3 | Completed | |||
2014/10/03 | Phase 3 | Completed | |||
2014/02/07 | Phase 2 | Completed | Institute of Cancer Research, United Kingdom | ||
2013/09/30 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 9/21/2009 | ||
Authorised | 9/21/2009 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
JAVLOR 25 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION | 09550009 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized | |
JAVLOR 25 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION | 09550011 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized | |
JAVLOR 25 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION | 09550001 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
JAVLOR 25 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION | 09550005 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
JAVLOR 25 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION | 09550003 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized | |
JAVLOR 25 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION | 09550007 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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