First and only drug releasing system is indicated for patients with BCG-unresponsive non-muscle-invasive bladder cancer seeking bladder preservation<\/p>\n<\/h3>\n
By Lori Solomon HealthDay Reporter<\/b>
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THURSDAY, Sept. 11, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved Inlexzo (gemcitabine intravesical system) for the treatment of patients with certain types of bladder cancer.<\/p>\n
Specifically, Inlexzo is indicated for the treatment of adult patients with Bacillus Calmette-Gu\u00e9rin (BCG)-unresponsive, non-muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors. The novel approach is designed for patients seeking bladder preservation and is the first and only intravesical drug-releasing system to provide extended local delivery.<\/p>\n
The approval was based on data from the SunRISe-1 single arm, open-label phase 2b clinical study. More than eight in 10 patients with BCG-unresponsive non-muscle-invasive bladder cancer treated with Inlexzo achieved a complete response (82 percent), with strong durability. Just over half of patients with a complete response maintained a complete response for at least one year (51 percent).<\/p>\n
“I see many patients that ultimately become BCG-unresponsive and often face life-altering bladder removal,” SunRISe-1 principal investigator Sia Daneshmand, M.D., from the University of Southern California in Los Angeles, said in a statement. “In my experience, Inlexzo is well tolerated and delivers clinically meaningful results. This will change the way we treat appropriate patients that haven’t responded to traditional therapy.”<\/p>\n
Approval of Inlexzo was granted to Johnson & Johnson. <\/p>\n