• New data from Johnson & Johnson's Phase IIb SunRISe-1 trial demonstrates high response rates for TAR-200 in patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer, with 82.4% achieving complete response.
• The drug-device combination, which continuously delivers gemcitabine directly to the bladder over a week, showed durable efficacy with 52.9% of responders maintaining complete response at one year and a median duration of response of 25.8 months.
• J&J has filed a New Drug Application with the FDA for TAR-200 in January 2025, which is being reviewed through the Real-Time Oncology Review program, potentially offering a new treatment option for a disease with few therapeutic advances in over 40 years.