Johnson & Johnson Receives FDA Priority Review for TAR-200 NDA for High-Risk Bladder Cancer Treatment

Johnson & Johnson's TAR-200, an intravesical gemcitabine releasing system, has been granted Priority Review by the FDA for treating BCG-unresponsive high-risk non-muscle invasive bladder cancer. The decision is based on data from the Phase 2b SunRISe-1 study. TAR-200 is an investigational treatment that was submitted for FDA approval in January 2025.

Johnson & Johnson (NYSE: JNJ) has received a significant regulatory milestone for its innovative intravesical gemcitabine releasing system, TAR-200. The U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) filed for TAR-200, which is designed to treat patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors [1].

The regulatory submission is supported by data from the Phase 2b SunRISe-1 study, which demonstrated an 82.4% complete response (CR) rate with 52.9% of patients remaining cancer-free at least one year or more after achieving a CR (95% confidence interval [CI], 72.6-89.8) [1]. The majority of adverse reactions were mild and moderate, with no systemic adverse reactions reported.

TAR-200 is the first and only intravesical drug releasing system (iDRS) designed to provide sustained local delivery of a cancer treatment into the bladder. It remains in the bladder for three weeks per treatment cycle and is inserted using a co-packaged urinary placement catheter in an outpatient setting, requiring no general anesthesia or further monitoring post-insertion [1].

The FDA's Priority Review designation is a significant step forward for TAR-200, which has been under investigation for its potential to fundamentally change the way urologists treat certain types of bladder cancer. The drug has shown promising results in clinical trials, with the SunRISe-1 study demonstrating high response rates and minimal adverse effects [1].

Despite advancements, the standard of care for patients with HR-NMIBC has remained largely unchanged for over 40 years, and patients have limited treatment options if initial BCG therapy does not work. TAR-200 offers a potential new treatment option for these patients, who may be unwilling or unfit to undergo radical cystectomy, a life-altering surgery with high morbidity and mortality rates [2].

Johnson & Johnson's commitment to innovation in healthcare is evident in the development of TAR-200. The company's expertise in Innovative Medicine and MedTech positions it well to deliver breakthroughs in healthcare solutions. The FDA's Priority Review for TAR-200 underscores the potential of this innovative treatment and highlights the company's ongoing efforts to improve patient outcomes.

References:
[1] https://www.marketscreener.com/news/johnson-johnson-receives-u-s-fda-priority-review-for-tar-200-nda-in-high-risk-non-muscle-invasive-ce7c5cd9df8df226
[2] https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-u-s-fda-priority-review-for-tar-200-nda-in-high-risk-non-muscle-invasive-bladder-cancer