FDA Approves J&J’s Inlexzo™ Breakthrough Bladder Cancer Therapy
Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has approved INLEXZO™ (gemcitabine intravesical system), a new and potentially practice-changing treatment for certain bladder cancers. The approval addresses the urgent need for additional options for patients whose disease persists after BCG therapy or who decline or are ineligible for radical cystectomy. INLEXZO™, previously known as TAR-200, is approved 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.
INLEXZO™ is the first and only drug-releasing system to provide extended local delivery of chemotherapy into the bladder, with 82 percent of patients achieving a complete response without the need for reinduction. A potentially practice-changing treatment for patients with BCG-unresponsive non-muscle invasive bladder cancer who have limited options before possible bladder removal.
INLEXZO™ is designed for patients seeking bladder preservation and is the first and only intravesical drug-releasing system (iDRS) to provide extended local delivery of chemotherapy directly into the bladder. The system remains in the bladder for three weeks per treatment cycle, for up to 14 cycles. A healthcare professional places INLEXZO™ using a co-packaged urinary catheter and stylet in just a few minutes in an outpatient setting, without the need for general anesthesia or additional monitoring immediately after insertion.
Jennifer Taubert, Executive Vice President, Worldwide Chairman, Innovative Medicine, Johnson & Johnson stated:
“When we acquired this novel therapy in 2019, our ambition was to give patients with bladder cancer a renewed sense of hope and belief. In an area that has seen little progress for more than 40 years, INLEXZO delivers a first-of-its-kind breakthrough innovation with a bright future ahead.”
SunRISe-1 Phase 2b Clinical Study Data Showed High Bladder Cancer Response
The approval is supported by data from the SunRISe-1 (NCT04640623) single arm, open-label Phase 2b clinical study. Results showed that 82 percent of patients with BCG-unresponsive NMIBC treated with INLEXZO™ achieved a complete response (CR), meaning no signs of cancer were detected after treatment (95 percent confidence interval [CI], 72–90). This high response rate demonstrated strong durability, with 51 percent of patients maintaining a complete response for at least one year.
In the SunRISe-1 trial, the most common adverse reactions (≥15 percent), including laboratory abnormalities, were 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 (AST), decreased sodium, bladder irritation, and increased alanine transaminase (ALT).
Sia Daneshmand, M.D., TAR-200 SunRISe-1 principal investigator, and Professor of Urology, Director of Urologic Oncology at the Norris Comprehensive Cancer Center, Keck School of Medicine of University of Southern California, stated:
“I see many patients that ultimately become BCG-unresponsive and often face life-altering bladder removal. These patients now may be ideal candidates for newly approved INLEXZO. In my experience, INLEXZO is well-tolerated and delivers clinically meaningful results. This will change the way we treat appropriate patients that haven’t responded to traditional therapy.”
John Reed, M.D., Ph.D., Executive Vice President, R&D, Innovative Medicine, Johnson & Johnson, commented:
“We are proud of the science that has brought us to this historic moment. INLEXZO is a novel therapy with powerful efficacy and demonstrated safety profile. As the only major healthcare company that hosts both pharmaceuticals and medical devices, we leveraged the speed and scale of Johnson & Johnson to accelerate innovation and deliver this important therapy to patients.”
Meri-Margaret Deoudes, CEO, Bladder Cancer Advocacy Network (BCAN) said:
“At BCAN, our mission has always been to advocate for better todays and more tomorrows for everyone impacted by bladder cancer. This approval represents the kind of progress that brings new options to a community that urgently needs them. Patients with bladder cancer need guidance and collaboration with providers to navigate bladder-sparing treatment options, including newly approved treatments like INLEXZO, so they can move forward feeling well-informed and confident.”
About INLEXZO™
INLEXZO™ is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. INLEXZO™ is an intravesical system enabling extended release of gemcitabine into the bladder. It is placed in a few minutes without general anesthesia or further monitoring immediately post-insertion within the healthcare provider’s office.
Image Creadits: © Johnson & Johnson and its affiliates 2025
Original Source: RARITAN, N.J., September 9, 2025 /PRNewswire/ – Johnson & Johnson – U.S. FDA approval of INLEXZO™ (gemcitabine intravesical system) set to transform how certain bladder cancers are treated
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