> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# J&J Touts Bladder Cancer Data in Recent NDA
- URL: https://www.fdaweb.com/j-j-touts-bladder-cancer-data-in-recent-nda/
- Published: 2025-04-28T12:00:00.000Z
- Updated: 2026-09-14T15:10:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159075

Johnson & Johnson says data from the Phase 2b SunRISe-1 study evaluating TAR-200, an intravesical gemcitabine releasing system, for patients with certain types of bladder cancer. “These first results show the promise of TAR-200 in this patient population with more than an 80% disease-free survival (DFS) rate without the need for reinduction and 94% of patients able to preserve their bladder,” a [company release](https://www.jnj.com/media-center/press-releases/johnson-johnsons-tar-200-monotherapy-achieves-high-disease-free-survival-of-more-than-80-percent-in-bcg-unresponsive-high-risk-papillary-nmibc?ref=fdaweb.com) says. “The high DFS and bladder preservation rate combined with the well-tolerated safety profile in these patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with papillary-only disease (high-grade Ta or T1) show the potential of TAR-200 as a meaningful alternative to surgery.”

The data release follows the company’s January NDA submission of TAR-200, which is being reviewed under the agency’s Real-Time Oncology Review program. At the time of submission, the company noted that the therapy 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.

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.