FDA Approves Inlexzo as a Breakthrough Treatment for Bladder Cancer
The FDA has approved Inlexzo, an innovative intravesical therapy for BCG-unresponsive bladder cancer, showing promising results in clinical trials and offering new hope for bladder preservation.
The U.S. Food and Drug Administration (FDA) has granted approval to Inlexzo (gemcitabine intravesical system), an innovative treatment designed for bladder cancer patients. This approval marks a significant advancement in the management of certain types of bladder cancer, especially for patients who have not responded to previous therapies.
Inlexzo is specifically indicated for use in adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer characterized by carcinoma in situ, with or without papillary tumors. The unique aspect of this treatment is its ability to deliver extended local drug release directly within the bladder, aiming to preserve the bladder and avoid more invasive procedures.
The FDA's decision was based on positive outcomes from the SunRISe-1 phase 2b clinical trial. Results showed that over 80% of patients achieved a complete response to the treatment, with more than half maintaining this response for at least a year. Dr. Sia Daneshmand, from the University of Southern California, highlighted that Inlexzo is not only well tolerated but also offers meaningful clinical benefits to patients facing limited options.
This approval provides new hope for bladder cancer patients who are BCG-unresponsive, offering an alternative to bladder removal and improving quality of life. Johnson & Johnson has been authorized to market Inlexzo, which represents a pioneering step in intravesical therapy.
For more details, source: https://medicalxpress.com/news/2025-09-fda-inlexzo-bladder-cancer.html
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