Core Points - Johnson & Johnson has submitted a New Drug Application for TAR-200 to the U.S. FDA for treating BCG-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) [1][2] - The submission is supported by Phase 2b SunRISe-1 study data, which demonstrated an 83.5% complete response rate and durable responses in patients [2][4] - TAR-200 is an innovative intravesical drug releasing system designed for sustained local delivery of gemcitabine into the bladder [2] Company Overview - Johnson & Johnson aims to address critical treatment needs for patients with limited therapeutic alternatives, particularly those facing radical cystectomy [2] - The company combines expertise in innovative medicine and medical devices to transform bladder cancer treatment [2][6] - The FDA granted Breakthrough Therapy Designation to TAR-200, highlighting its potential significance in treating adult patients with HR-NMIBC [3] Industry Context - High-risk non-muscle-invasive bladder cancer (HR-NMIBC) represents 15-44% of NMIBC cases and is characterized by high recurrence and progression rates [5] - Current treatment options for patients failing BCG therapy are limited, often leading to radical cystectomy, which may not be suitable for older patients [5] - The introduction of TAR-200 could provide a less invasive alternative, potentially improving patient outcomes and quality of life [2][5]
New Drug Application initiated with U.S. FDA for TAR-200, the first and only intravesical drug releasing system for patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer