Pune, India | September 10, 2025
The U.S. Food and Drug Administration (FDA) has approved Inlexzo, a new treatment for bladder cancer. Developed by Janssen Biotech, Inc., it targets adults with non-muscle invasive bladder cancer (NMIBC) who have not responded to bacilli Calmette-Guérin (BCG) therapy. Inlexzo is indicated for patients with carcinoma in situ (CIS), with or without papillary tumors. It offers a less invasive alternative to surgery for those with limited treatment options.
Inlexzo delivers gemcitabine, a well-established chemotherapy drug, directly into the bladder. A specialized system introduces the drug via a catheter. Each dose includes 225 mg of gemcitabine and stays in the bladder for about three hours before removal. Patients receive one dose every three weeks for six months, followed by maintenance doses every 12 weeks for up to 18 months. Treatment is done in outpatient clinics and does not require anesthesia.
The FDA based its approval on results from the SunRISe-1 clinical trial (Cohort 2). The study included 83 patients with BCG-unresponsive NMIBC. Inlexzo achieved a complete response rate (CR) of 82%, with a 95% confidence interval between 72% and 90%. More than half of the responders remained cancer-free for at least a year. These results highlight the drug’s ability to eliminate cancer and reduce the risk of early recurrence.
To speed up access, the FDA used multiple accelerated pathways. These included Breakthrough Therapy designation, Priority Review, and the Assessment Aid program. These tools reflect the agency’s focus on bringing effective treatments to patients quickly, especially in cases of serious or rare diseases.
Inlexzo represents a breakthrough for patients who previously faced radical cystectomy, a procedure that removes the entire bladder. For many, especially older adults or those with other conditions, surgery is not a good option. Inlexzo provides bladder preservation without compromising on treatment effectiveness. It brings hope to patients seeking non-surgical alternatives.
Despite its benefits, the treatment carries some risks. The FDA advises against using it in patients with a perforated bladder. In some cases, delaying surgery might raise the risk of cancer spread. Patients should also be informed that MRI scans are unsafe while the system is in use. As the drug may harm an unborn baby, doctors must discuss pregnancy risks before starting therapy. Open discussions and informed decisions are essential.
Inlexzo joins a growing list of innovative treatments for NMIBC, such as Adstiladrin, Anktiva with BCG, and Zusduri. While each therapy has unique features, they all promote bladder-sparing, personalized care. Together, they offer more options for both urologists and oncologists managing this condition.
Among these, Inlexzo stands out for its high response rate and ease of use. Patients can receive treatment in clinics without being admitted to a hospital. This reduces both emotional and logistical stress. Its success also supports a shift toward managing NMIBC without major surgery.
Looking forward, Inlexzo could reshape treatment strategies for this difficult cancer. Clinical teams will monitor real-world outcomes and gather patient feedback to improve care. Ongoing education, safety reviews, and teamwork will play key roles in treatment success.
For those living with BCG-unresponsive bladder cancer, Inlexzo offers a new path forward. It avoids major surgery, targets the cancer directly, and helps patients maintain their daily lives. Its approval is a major milestone in the fight against bladder cancer.
