Johnson & Johnson Presents Promising New Data for Bladder Cancer Treatment at AUA 2025

Johnson & Johnson unveiled new clinical data at the American Urological Association 2025 Annual Meeting supporting its investigational bladder cancer treatment, TAR-200. Highlights include 12-month results from Cohort 2 of the Phase 2b SunRISe-1 study, which showed the highest complete response rates to date in patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ. First results from Cohort 4 demonstrated the potential of TAR-200 as a monotherapy for papillary-only HR-NMIBC.

TAR-200 is a gemcitabine-releasing intravesical system designed for bladder insertion via outpatient procedure, offering a bladder-sparing alternative for patients often unfit or unwilling to undergo radical cystectomy. The innovation has now been used over 10,000 times in the SunRISe clinical program.

Additional updates from Johnson & Johnson’s pipeline include Phase 3 trials for TAR-210, a similar erdafitinib-based delivery system, and ongoing studies in both bladder and prostate cancer.

The company has submitted a new drug application for TAR-200 to the FDA under its real-time oncology review program, with Breakthrough Therapy Designation granted in 2023. These findings aim to advance more tolerable, non-surgical solutions for patients with recurring bladder cancer.