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Today, Johnson & Johnson announced that the U.S. FDA has granted Priority Review designation to the New Drug Application (NDA) for its innovative intravesical drug delivery system TAR-200, intended for the treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ in patients who are unresponsive to Bacillus Calmette-Guérin (BCG).According to the press release, TAR-200 is the first intravesical drug release system (iDRS) designed to provide sustained local drug delivery for bladder cancer treatment.

High-risk non-muscle-invasive bladder cancer is a type of non-invasive bladder cancer that is more likely to recur or spread to the inner layer of the bladder and progress to muscle-invasive bladder cancer. Compared with low-risk non-muscle-invasive bladder cancer, it carries a higher risk of progression. Currently, for patients with non-muscle-invasive bladder cancer who fail BCG treatment, radical cystectomy is recommended. If surgery is performed before progression to muscle-invasive bladder cancer, the cancer-specific survival rate exceeds 90%. Considering that non-muscle-invasive bladder cancer typically affects elderly patients, many are unwilling or unsuitable to undergo radical cystectomy. The high recurrence and progression rates may impose a significant disease burden and psychological distress on these patients.

This new drug application is mainly based on the data support from the Phase 2b SunRISe-1 study. Analysis shows,TAR-200 induced complete response (CR) in 82.4% of patients, with 52.9% of patients maintaining a cancer-free status for at least one year or longer after achieving CR (95% CI: 72.6-89.8).

Most adverse reactions were mild to moderate. The most common adverse reactions (incidence ≥10%) included: urinary frequency, difficulty in urination, urinary tract infection, urgency of urination, hematuria, non-infectious cystitis, and urinary tract pain. No systemic adverse reactions were observed.

▲TAR-200 (Image Source: Reference [1])

TAR-200It is an investigational intravesical drug delivery system designed to achieve sustained local release of gemcitabine in the bladder, maintaining local drug exposure for up to several weeks.The system is implanted in the bladder by medical professionals through a配套的尿道放置导管 in an outpatient setting, taking less than five minutes without anesthesia.In each treatment cycle, TAR-200 can remain in the bladder for three weeks.2023Year12Month, United StatesFDAGrantTAR-200Breakthrough Therapy Designation (BTD), used to treat patients who are not suitable for or choose not to undergo radical cystectomy, forBCGPatients with high-risk non-muscle-invasive bladder cancer and carcinoma in situ who do not respond to treatment.

References:

[1] Johnson & Johnson receives U.S. FDA Priority Review for TAR-200 NDA in high-risk non-muscle invasive bladder cancer. Retrieved July 17, 2025 from https://www.prnewswire.com/news-releases/johnson--johnson-receives-us-fda-priority-review-for-tar-200-nda-in-high-risk-non-muscle-invasive-bladder-cancer-302507112.html

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