Negative NICE final guidance for Pierre Fabre's Javlor in bladder cancer; fast-track FAD for Eliquis

In final guidance published (January 23, 2013), UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has not recommended National Health Service use of French independent drugmaker Pierre Fabre’s Javlor (vinflunine) for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract which has progressed following prior treatment with platinum-containing chemotherapy. This confirms a previous negative draft final guidance on the drug (The Pharma Letter March 11, 2011).

Commenting on the guidance, NICE chief executive Sir Andrew Dillon said: “When we recommend the use of expensive treatments designed to extend life, we need to be confident about the nature and the extent of the benefit they bring. In the case of vinflunine, the manufacturer has been unable to provide the Appraisal Committee with conclusive evidence on how effective vinflunine is, particularly the extent to which it can prolong survival compared with best supportive care.”

Pierre Fabre estimated that around 800-1,500 people would be eligible to receive this drug according to its licence. In the study submitted by the manufacturer, best supportive care included palliative radiotherapy, antibiotics, analgesics, corticosteroids and blood transfusions. Although there is some evidence to indicate that vinflunine can extend life for patients with transitional cell carcinoma, there is considerable uncertainty around the estimates provided by the manufacturer.