Johnson & Johnson's TAR-200 Receives FDA Priority Review for Bladder Cancer Treatment

Johnson & Johnson (JNJ) has received priority review from the FDA for its new drug application for TAR-200, a drug-releasing system for bladder cancer. TAR-200 is a non-surgical treatment option for patients with bladder cancer. The FDA review process is expected to be completed by May 2023.

Johnson & Johnson (JNJ) has received priority review from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for TAR-200, an innovative intravesical drug-releasing system designed to treat high-risk non-muscle invasive bladder cancer (HR-NMIBC) in patients unresponsive to Bacillus Calmette-Guérin (BCG) therapy. This development represents a significant advancement in the treatment of bladder cancer, offering a non-surgical option for patients with limited treatment alternatives.

TAR-200 is an intravesical gemcitabine releasing system that is inserted into the bladder through a brief outpatient procedure. It remains in the bladder for three weeks per cycle, providing sustained local delivery of the cancer treatment. The FDA's priority review underscores the potential of TAR-200 to fundamentally change the way urologists treat certain types of bladder cancer.

The regulatory submission for TAR-200 is supported by data from the Phase 2b SunRISe-1 study, which demonstrated an impressive 82.4% complete response (CR) rate. Additionally, 52.9% of patients remained cancer-free for at least one year or more after achieving a complete response. The study also reported that the majority of adverse reactions were mild and moderate, with no systemic adverse reactions noted [1].

TAR-200 is the first and only intravesical drug-releasing system designed to provide sustained local delivery of a cancer treatment into the bladder. It can be administered in an outpatient setting in under five minutes, requiring no general anesthesia or immediate post-insertion monitoring. This innovation addresses a critical unmet need for patients with HR-NMIBC, who often have limited treatment options if initial BCG therapy fails [2].

The FDA's priority review process is expected to be completed by May 2023, which could accelerate the availability of TAR-200 for patients. If approved, TAR-200 has the potential to significantly impact the treatment landscape for HR-NMIBC, offering a less invasive and more effective alternative to radical cystectomy.

References:
[1] 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
[2] https://www.stocktitan.net/news/JNJ/johnson-johnson-receives-u-s-fda-priority-review-for-tar-200-nda-in-kurgc1nviow4.html