Gemcitabine Intravesical System Receives FDA Approval for Non–Muscle Invasive Bladder Cancer

The FDA has approved the gemcitabine (Gemzar; Eli Lilly and Company) intravesical system (Inlexzo; Johnson & Johnson) for the treatment of certain types of bladder cancer. Specifically, the new therapy is intended for adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. The drug releasing system (iDRS) offers further treatment options for patients who have not responded to BCG therapy or are unable or unwilling to undergo bladder removal surgery.¹

Image credit: Johnson & Johnson

"When we acquired this novel therapy in 2019, our ambition was to give patients with bladder cancer a renewed sense of hope and belief," Jennifer Taubert, executive vice president, worldwide chairman, innovative medicine, Johnson & Johnson, said in a news release. "In an area that has seen little progress for more than 40 years, [gemcitabine intravesical system] delivers a first-of-its-kind breakthrough innovation with a bright future ahead."¹

Overview of Non–Muscle Invasive Bladder Cancer

NMIBC is a form of noninvasive bladder cancer that is classified as low, intermediate, or high risk, which is determined by the tumor size, presence of multiple tumors, and CIS. If the cancer is found in its early stages, survival rates are high following treatment, according to the Urology Care Foundation. Currently, the standard of care for NMIBC is BCG and radical cystectomy for patients who fail BCG therapy. However, since NMIBC commonly impacts older patients, many may not be able to undergo radical cystectomy due to its high degree of mortality and adverse effects (AEs) on daily life.¹

"I see many patients that ultimately become BCG-unresponsive and often face life-altering bladder removal. These patients now may be ideal candidates for the newly approved [gemcitabine intravesical system]," Sia Daneshmand, MD, TAR-200 SunRISe-1 principal investigator, professor of urology, and director of urologic oncology at the Norris Comprehensive Cancer Center, Keck School of Medicine of the University of Southern California, said in the news release. "In my experience, [the gemcitabine intravesical system] is well-tolerated and delivers clinically meaningful results. This will change the way we treat appropriate patients that haven't responded to traditional therapy."¹

As an iDRS that enables extended release of gemcitabine into the bladder, the system provides an additional treatment option for patients that are unresponsive to BCG or have NMBIC with CIS, with or without papillary tumors. The gemcitabine iDRS can be inserted in a matter of minutes by a health care provider and does not require general anesthesia or further monitoring after it is inserted.¹

"Patients with bladder cancer need guidance and collaboration with providers to navigate bladder-sparing treatment options, including newly approved treatments like [gemcitabine intravesical system], so they can move forward feeling well-informed and confident," Meri-Margaret Deoudes, CEO, Bladder Cancer Advocacy Network (BCAN), said in the news release.¹

Data From SunRISe-1 Clinical Trial

The FDA approval is based on data from the single-arm, open-label, phase 2b SunRISe-1 clinical trial (NCT04640623), which assessed the safety and efficacy of the intravesical gemcitabine system as a monotherapy for NMIBC patients that did not respond to prior treatments. The results demonstrated that 82% of patients treated with iDRS achieved a complete response with no signs of cancer after treatment. Among the 82% of patients, the study authors noted that approximately 51% maintained a complete response for at least 1 year.^1,3

The most common AEs with treatment included laboratory abnormalities, urinary frequency, urinary tract infection, dysuria, micturition urgency, decreased hemoglobin, increased lipase, urinary tract pain, decreased lymphocytes, hematuria, increased creatinine, increased potassium, increased aspartate aminotransferase, decreased sodium, bladder irritation, and increased alanine transaminase—occurring in less than 15% of patients.¹

"We are proud of the science that has brought us to this historic moment," John Reed, MD, PhD, executive vice president, R&D, innovative medicine, Johnson & Johnson, concluded in the news release. "[Gemcitabine intravesical system] is a novel therapy with powerful efficacy and a demonstrated safety profile."¹

REFERENCES

1. U.S. FDA approval of INLEXZO™ (gemcitabine intravesical system) set to transform how certain bladder cancers are treated. Johnson & Johnson. News release. September 9, 2025. Accessed September 10, 2025. https://www.multivu.com/johnson-and-johnson/9342851-en-johnson-and-johnson-fda-approval-inlexzo-gemcitabine-intravesical-system

2. What is Non-Muscle Invasive Bladder Cancer? Urology Care Foundation. News release. Updated June 2024. Accessed September 10, 2025. https://www.urologyhealth.org/urology-a-z/n/non-muscle-invasive-bladder-cancer

3. A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy (SunRISe-1). National Library of Medicine. Updated August 17, 2025. Accessed September 10, 2025. https://clinicaltrials.gov/study/NCT04640623