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Vinflunine

Generic Name
Vinflunine
Brand Names
Javlor
Drug Type
Small Molecule
Chemical Formula
C45H54F2N4O8
CAS Number
162652-95-1
Unique Ingredient Identifier
5BF646324K

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

Published: Jul 31, 2025

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:

Continue reading the full research report

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
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
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
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
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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