Pune, India | September 10, 2025
The U.S. Food and Drug Administration (FDA) has approved Inlexzo, a new treatment for bladder cancer. Janssen Biotech, Inc. developed this gemcitabine intravesical system for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Specifically, it targets patients with carcinoma in situ (CIS), with or without papillary tumors. Consequently, Inlexzo offers a less invasive alternative to radical surgery for those with limited options.
Inlexzo delivers the chemotherapy drug gemcitabine directly into the bladder using a specialized intravesical system inserted via a catheter. Each dose contains 225 mg of gemcitabine and remains in the bladder for about three hours before removal. Treatment occurs once every three weeks for six months, followed by maintenance doses every 12 weeks for up to 18 months. Importantly, doctors perform this therapy in outpatient clinics without anesthesia.
The FDA based approval on data from Cohort 2 of the SunRISe-1 trial (NCT04640623), which included 83 patients with BCG-unresponsive NMIBC. The trial showed that Inlexzo achieved a complete response (CR) rate of 82% (95% confidence interval: 72%-90%). Moreover, over half of the responders remained cancer-free for at least 12 months. These results demonstrate that Inlexzo effectively eliminates cancer and reduces the risk of early recurrence.
To speed approval, the FDA granted Inlexzo Breakthrough Therapy designation, Priority Review, and employed the Assessment Aid program. Therefore, these steps reflect the agency’s commitment to fast-tracking treatments for serious conditions with unmet needs.
Inlexzo represents a major advance for patients with few options. Many previously faced radical cystectomy, which involves removing the bladder completely. However, this surgery is not suitable or desirable for everyone. In contrast, Inlexzo preserves the bladder while effectively controlling cancer. It especially benefits elderly patients or those with other health issues.
Nevertheless, patients should consider the risks. The FDA advises against Inlexzo use in patients with bladder perforation. Additionally, delaying surgery could raise the risk of cancer spreading. Doctors must inform patients that MRI scans are unsafe while the system is in place. Also, because the drug may harm an unborn baby, reproductive safety must be discussed before treatment. Thus, careful decision-making is crucial.
Inlexzo joins a growing list of innovative NMIBC treatments, including Adstiladrin (nadofaragene firadenovec-vncg), Anktiva (nogapendekin alfa inbakicept-pmln with BCG), and Zusduri (mitomycin intravesical solution). Each treatment offers unique benefits and advances personalized, bladder-sparing care. Together, they significantly expand options for oncologists and urologists.
Among these options, Inlexzo stands out due to its high CR rate and ease of use. Patients receive treatment in outpatient settings without hospitalization, which reduces logistical and emotional burdens. Moreover, its success supports the trend of treating NMIBC without invasive surgery.
Looking ahead, Inlexzo may transform how doctors manage this challenging bladder cancer. Medical teams will monitor real-world outcomes to confirm long-term safety and effectiveness. They will also gather patient feedback to optimize treatment. Therefore, patient education, safety checks, and coordinated care will be key to success.
For patients with BCG-unresponsive bladder cancer, Inlexzo offers new hope. It avoids major surgery, targets cancer directly, and helps patients maintain their daily lives. Ultimately, this approval marks a significant step forward in modern bladder cancer treatment.
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