Posted by Michael Wonder on 15 Jan 2025
New drug application initiated with US FDA for TAR-200, the first and only intravesical drug releasing system for patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer
15 January 2025 - Application accepted for US FDA Real-Time Oncology Review based on Phase 2b SunRISe-1 study showing highest single-agent complete response rate of 83.5 percent.
Johnson & Johnson announced it has initiated the submission of an original new drug application with the US FDA for TAR-200 for the treatment of patients with Bacillus Calmette-Guérin unresponsive high-risk non-muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumours.
