New Intravesical Treatment System Approved for Early-stage Bladder Cancer
The FDA has approved a delivery system that, once inserted into the bladder, delivers a local dose of the drug gemcitabine.
The U.S. Food and Drug Administration (FDA) has approved a gemcitabine intravesical system (Inlexzo) for the treatment of non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors, that is not responsive to Bacillus Calmette-Guérin.
The gemcitabine intravesical system—a small, pretzel-shaped tube containing miniature tablets of the drug—comes with a urinary catheter and a thin probe that health care providers use to administer the drug delivery system into the patient’s bladder. Once inserted, the system disperses gemcitabine into the bladder, and the system remains in the bladder for about three weeks before it is removed. A cancer chemotherapeutic, gemcitabine kills cells undergoing DNA synthesis (a process that disproportionately affects cancer cells, which multiply and replicate much more rapidly than other cells).
Gemcitabine received its first FDA approval in 1996 as an injectable therapy to treat ovarian, breast, pancreatic, and non-small cell lung cancers. Since then, gemcitabine has been researched as a treatment for an expanded range of cancer types, including bladder cancer. Unlike prior methods that have been explored to deliver gemcitabine into the bladder, the newly FDA-approved intravesical system slowly delivers a steady dose of gemcitabine over an extended period of time, thereby reducing the number of catheterization procedures the patient needs to undergo.
The approval of the intravesical gemcitabine system is based on results from the second cohort of the single-arm, multicenter phase IIb SunRISe-1 clinical trial, which enrolled 83 patients who had NMIBC with carcinoma in situ, with or without papillary tumors, that did not respond to treatment with Bacillus Calmette-Guérin (a longstanding treatment for bladder cancer that uses a weakened bacterial strain to stimulate the immune response). The patients were treated with the intravesical gemcitabine system and underwent cystoscopy and urine cytology every 12 weeks to evaluate their tumors.
Eighty-two percent of patients experienced a complete response, defined as negative results for bladder cancer on both cystoscopy and urine cytology evaluations. Fifty-one percent of the complete responses endured for at least 12 months.
After intravesical administration, the gemcitabine intravesical system is left in the bladder for about three weeks, during which time it delivers 225 mg of gemcitabine. It is recommended that a new system be administered once every three weeks for a period of up to six months (the equivalent of eight doses), followed by once every 12 weeks for up to 18 months (the equivalent of six doses). The FDA recommends stopping treatment if patients experience persistent or recurrent high-grade NMIBC, disease progression, or unacceptable toxicity.
Bladder cancer, which tends to affect older adults, forms within the bladder and can be described as either non-muscle-invasive—meaning that the cancer has not reached the bladder’s muscle wall—or muscle-invasive, which is bladder cancer that has permeated the muscle tissue immediately outside the bladder. When malignant cells form in flat lesions within the bladder’s lining, that bladder cancer is considered to be carcinoma in situ, an early-stage disease that may or may not be accompanied by additional rounded (papillary) malignant lesions. According to federal statistics, it was estimated that 84,870 individuals would be diagnosed with bladder cancer and 17,420 patients would die of the disease in the United States in 2025.
The FDA rendered its decision on September 9, 2025. Check this resource for updated information on all therapeutics regulated by the FDA.