following a resubmission considered under the end of life process.
vinflunine (Javlor®) is not recommended for use within NHS Scotland.
Indication under review: monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen. Efficacy and safety of vinflunine have not been studied in patients with performance status ≥ 2.
Vinflunine plus best supportive care was associated with improved survival when compared with best supportive care alone in the second-line treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract in patients with good performance status.
The submitting company did not present a sufficiently robust economic analysis and in addition their justification of the treatment’s cost in relation to its benefits was not sufficient to gain acceptance by SMC.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Download detailed advice208KB (PDF)
Medicine details
- Medicine name:
- vinflunine (Javlor)
- SMC ID:
- 686/11
- Indication:
- Monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen. Efficacy and safety of vinflunine have not been studied in patients with performance status ≥ 2.
- Pharmaceutical company
- Pierre Fabre Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Resubmission
- Status
- Not recommended
- Date advice published
- 13 July 2015