Johnson & Johnson (JNJ) announced promising new data from Phase 2b SunRISe-1 study of TAR-200, an intravesical gemcitabine releasing system for bladder cancer treatment. The study showed remarkable results with 82.4% of 85 enrolled patients achieving complete response, and 52.9% of responders maintaining cancer-free status at one year.
The median duration of response was 25.8 months, with 86.6% of responders remaining cystectomy-free at 12 months. The treatment demonstrated strong safety profile, with mostly mild urinary symptoms reported. Of the 83.5% patients experiencing treatment-related adverse events, only 12.9% reported Grade 3 or higher events.
TAR-200, administered through a brief outpatient procedure, represents a potential breakthrough for patients with BCG-unresponsive, high-risk non-muscle invasive bladder cancer. The company has initiated a new drug application with the FDA under the Real-Time Oncology Review program in January 2025.Johnson & Johnson (JNJ) announced promising new data from Phase 2b SunRISe-1 study of TAR-200, an intravesical gemcitabine releasing system for bladder cancer treatment. The study showed remarkable results with 82.4% of 85 enrolled patients achieving complete response, and 52.9% of responders maintaining cancer-free status at one year.
The median duration of response was 25.8 months, with 86.6% of responders remaining cystectomy-free at 12 months. The treatment demonstrated strong safety profile, with mostly mild urinary symptoms reported. Of the 83.5% patients experiencing treatment-related adverse events, only 12.9% reported Grade 3 or higher events.
TAR-200, administered through a brief outpatient procedure, represents a potential breakthrough for patients with BCG-unresponsive, high-risk non-muscle invasive bladder cancer. The company has initiated a new drug application with the FDA under the Real-Time Oncology Review program in January 2025.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.