J&J wins full approval for bladder cancer drug

The FDA on Fri­day con­vert­ed its ac­cel­er­at­ed ap­proval of John­son & John­son’s blad­der can­cer drug Balver­sa to a full ap­proval.

Balver­sa, al­so known as erdafi­tinib, be­came the first FDA-ap­proved FGFR ki­nase in­hibitor in 2019 af­ter a small­er study showed that al­most one-third of blad­der can­cer pa­tients saw their tu­mors shrink. The full ap­proval comes six weeks ahead of sched­ule and fea­tures sev­er­al changes to the la­bel.

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