Non-muscle invasive bladder cancer (NMIBC) is classified as low, intermediate, or high risk, depending on size, multiplicity, and presence of carcinoma in situ (CIS), which occurs in approximately 10% of cases. The standard treatment for NMIBC is Bacillus Calmette-Guérin (BCG) immunotherapy, but some patients become unresponsive. After BCG failure, the remaining treatment option is radical cystectomy, an extensive surgery with significant morbidity. Substantial risks or morbidities from bladder removal include death (3-8%). Still, it may also alter the patient’s lifestyle, especially for older patients or those unsuitable for extensive surgery, underscoring the urgent need for alternative NMIBC therapies.
INLEXZO (gemcitabine intravesical system) has recently been approved by the U.S Food and Drug Administration (FDA), representing a new treatment modality for certain NMIBC patients. This therapy is aimed at expanding options for patients who are unresponsive to BCG treatment or who are not willing to undergo radical cystectomy (removal of the bladder). Previously, INLEXZO (previously called TAR-200) was used specifically in adult patients with NMIBC in CIS, either alone or in combination with papillary tumors.
INLEXZO is the first intravesical drug-releasing system (iDRS) that provides a bladder-sparing therapy for sustained and localized therapy. The device is inserted into the bladder for three weeks per cycle, with a total usage of up to 14 cycles. A catheter and stylet provide a method of placement that is carried out by a healthcare provider and typically in an outpatient setting. The procedure is quick, usually completed in a few minutes, and does not need any general anesthesia or post-insertion follow-up.
This approval was based on the results of the SunRISe-1 Phase 2b trial (NCT04640623) in which 82% of patients with BCG-unresponsive NMIBC who received INLEXZO therapy achieved a complete response (CR) (95% confidence interval [CI]: 72-90). Durability was demonstrated, with 51% maintaining CR at one year.
The most common adverse events (≥15 ) observed in the SunRISe-1 trial included laboratory abnormalities (Changes in hemoglobin, lymphocytes, creatinine, potassium, sodium, lipase, AST, and ALT) and urinary symptoms such as bladder pain/irritation, hematuria, urgency, dysuria, urinary tract infection, and urinary frequency.
Many patients ultimately develop BCG-unresponsiveness and face radical cystectomy, which can significantly change their lives. These patients are now suitable candidates for the newly approved INLEXZO, said Sia Daneshmand, M.D., principal investigator of the TAR-200 SunRISe-1 trial and Professor of Urology, Director of Urologic Oncology at the Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California. My personal experience shows that INLEXZO is well-tolerated and delivers meaningful clinical outcomes, which provide a valuable new treatment option for patients not responding to standard therapies.
We are proud of the science behind this milestone,” said John Reed, Executive Vice President of Research & Development, Innovative Medicine, Johnson & Johnson. “INLEXZO is a novel therapy demonstrating remarkable efficacy and safety. With a collaboration between Johnson & Johnson’s pharmaceuticals and medical devices expertise, we were able to accelerate its development and bring this important treatment to patients.”
References: Johnson & Johnson. U.S. FDA approval of INLEXZO™ (gemcitabine intravesical system) set to transform how certain bladder cancers are treated. Published September 9, 2025. Accessed September 12, 2025. U.S. FDA approval of INLEXZO™ (gemcitabine intravesical system) set to transform how certain bladder cancers are treated
