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# J&J Bladder Cancer Drug Under Review
- URL: https://www.fdaweb.com/j-j-bladder-cancer-drug-under-review/
- Published: 2025-01-15T12:00:00.000Z
- Updated: 2026-09-14T14:50:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158493

FDA has accepted for review a Johnson & Johnson NDA for TAR-200 (gemcitabine), an intravesical drug-releasing system for treating patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ, with or without papillary tumors. The company says the submission is being reviewed under the agency’s Real-Time Oncology Review program, which allows data to be reviewed before the complete application is formally submitted.

The submission is based on data from the Phase 2b SunRISe-1 registration study that “showed an 83.5% complete response (CR) rate and highly durable CRs without the need for reinduction,” J&J says. The data also demonstrated a low occurrence of Grade 3 or higher treatment-related adverse events (9%); five patients had adverse events leading to discontinuation (6%) and no treatment-related deaths were reported, it adds.

The intravesical drug-releasing system is designed to provide sustained local delivery of gemcitabine into the bladder, J&J says. “It is placed into the bladder by a healthcare professional using a co-packaged urinary placement catheter in an outpatient setting in under five minutes and without the need for anesthesia,” it says.

J&J says that HR-NMIBC is more likely to recur or spread beyond the lining of the bladder (urothelium) and progress to invasive bladder cancer compared to low-risk NMIBC.