Johnson & Johnson's breakthrough therapy granted priority review status, with over 80% of patients tumors completely disappearing.

Today, Johnson & Johnson (JNJ.US) announced that the U.S. FDA has granted its innovative bladder drug release system TAR-200 a priority review for a New Drug Application (NDA) for the treatment of high-risk non-muscle invasive bladder cancer (HR-NMIBC) patients with in-situ tumors who are unresponsive to Bacillus Calmette-Guerin (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 prone to recur or spread to the inner layers of the bladder and progress to muscle-invasive bladder cancer, with a higher risk of progression compared to low-risk non-muscle invasive bladder cancer. Currently, for patients with non-muscle invasive bladder cancer who have failed BCG therapy, radical cystectomy is recommended. If surgery is performed before the cancer progresses to muscle-invasive bladder cancer, the cancer-specific survival rate exceeds 90%. Considering that non-muscle invasive bladder cancer commonly affects elderly patients, many are unwilling or unsuitable for radical cystectomy, and the high recurrence and progression rates may cause significant disease burden and psychological distress for these patients. This new drug application is mainly based on data from the phase 2b SunRISe-1 study. Analysis showed that TAR-200 achieved complete remission (CR) in 82.4% of patients, and 52.9% of patients maintained cancer-free status for at least one year or longer after achieving CR (95% CI: 72.6-89.8). TAR-200 is an investigational intravesical drug release system designed to achieve continuous local release of gemcitabine in the bladder, maintaining local drug exposure for several weeks.