US FDA approval of Inlexzo (gemcitabine intravesical system) set to transform how certain bladder cancers are treated

Johnson & Johnson

9 September 2025 - First and only drug releasing system to provide extended local delivery of a cancer medication into the bladder, with 82 percent of patients achieving complete response without the need for re-induction.

Johnson & Johnson announced today the US FDA approved Inlexzo (gemcitabine intravesical system), a new, potentially practice-changing approach for treating patients with certain types of bladder cancer, addressing the need for additional options following unsuccessful BCG therapy and for patients refusing or ineligible for bladder removal surgery (radical cystectomy).

Read Johnson & Johnson press release

Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , US , Registration