Javlor vinflunine regulatory update

The U.K.'s NICE issued a second final appraisal determination (FAD) recommending against the use of Javlor vinflunine from Pierre Fabre to treat advanced or metastatic transitional cell carcinoma of the urothelial tract that has progressed following prior treatment - its approved indication. The agency said the most plausible incremental cost-effectiveness ratio (ICER) for Javlor plus best supportive care (BSC) compared with BSC alone was greater than £120,000 ($190,608) per quality-adjusted life year (QALY). NICE usually considers products with ICERs less than or equal to £30,000 per QALY to be cost-effective. Comments are due by Nov. 22. ...