Johnson & Johnson receives U.S. FDA Priority Review for TAR-200 NDA in high-risk non-muscle invasive bladder cancer

Core Viewpoint - Johnson & Johnson announced that the FDA granted Priority Review for TAR-200, an innovative intravesical gemcitabine releasing system aimed at treating high-risk non-muscle invasive bladder cancer patients who are unresponsive to BCG therapy [1][3]. Company Overview - Johnson & Johnson is focused on healthcare innovation, aiming to transform treatment approaches for complex diseases and improve patient outcomes through less invasive solutions [8]. Product Details - TAR-200 is designed to be inserted into the bladder through a brief outpatient procedure, remaining in place for three weeks per treatment cycle [2][4]. - The product is the first intravesical drug releasing system (iDRS) that provides sustained local delivery of cancer treatment into the bladder [3][4]. Clinical Study Insights - The Phase 2b SunRISe-1 study showed an 82.4% complete response rate, with 52.9% of patients remaining cancer-free for at least one year after achieving a complete response [3][5]. - The study primarily evaluated the safety and efficacy of TAR-200 in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer [5]. Regulatory Milestones - In January 2025, Johnson & Johnson initiated a New Drug Application with the FDA for TAR-200 under the Real-Time Oncology Review program [4]. - The FDA previously granted Breakthrough Therapy Designation to TAR-200 in December 2023 for the same patient population [4]. Market Context - High-risk non-muscle invasive bladder cancer (HR-NMIBC) represents a significant unmet medical need, with limited treatment options available for patients who do not respond to BCG therapy [6][7]. - Approximately 10% of patients with non-muscle invasive bladder cancer have HR-NMIBC with carcinoma in situ [6].