U.S. FDA approval of INLEXZO™ (gemcitabine intravesical system) set to transform how certain bladder cancers are treated

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 reinduction1 Potential practice-changing treatment for certain patients with BCG-unresponsive non-muscle invasive bladder cancer who have limited options before possible bladder removal RARITAN, N.J. , Sept. 9, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today the U.S. Food and Drug Administration (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).1 INLEXZO™, previously referred to as TAR-200, is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.1 Multimedia assets for media are available here.