U.S. FDA approves INLEXZO™ (gemcitabine intravesical system), set to transform treatment for certain bladder cancers
Wednesday, September 10, 2025
Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved INLEXZO™ (gemcitabine intravesical system), a new approach for treating patients with specific types of bladder cancer. The therapy is intended for adults with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours, who are seeking alternatives to bladder removal surgery (radical cystectomy).
Previously known as TAR-200, INLEXZO™ is the first and only intravesical drug releasing system (iDRS) that provides extended local delivery of cancer medication directly into the bladder. The device remains in place for three weeks per treatment cycle, for up to 14 cycles. A healthcare professional inserts INLEXZO™ in an outpatient setting using a urinary catheter and stylet, a procedure that takes only a few minutes and does not require general anaesthesia.
Jennifer Taubert, Executive Vice President, Worldwide Chairman, Innovative Medicine, Johnson & Johnson, said:
"When we acquired this novel therapy in 2019, our goal was to offer patients with bladder cancer a renewed sense of hope. INLEXZO represents a first-of-its-kind breakthrough in an area where little progress has been made for over 40 years."
The FDA’s approval is supported by data from the SunRISe-1 (NCT04640623) Phase 2b clinical study. Results showed that 82% of patients treated with INLEXZO™ achieved a complete response (no detectable cancer), with 51% maintaining this response for at least one year.
The most common side effects (≥15%) included urinary frequency, urinary tract infection, painful urination, urgency, haematuria, bladder irritation, and some laboratory abnormalities such as changes in hemoglobin, lipase, creatinine, potassium, sodium, AST, and ALT levels.
Sia Daneshmand, M.D., principal investigator of SunRISe-1 and Professor of Urology at the Keck School of Medicine, University of Southern California, commented:
"Many patients become BCG-unresponsive and face life-changing bladder removal. INLEXZO offers an important new option, showing strong clinical results with a tolerable safety profile. This approval will change how we treat appropriate patients who have not responded to standard therapies."
John Reed, M.D., Ph.D., Executive Vice President, R&D, Innovative Medicine, Johnson & Johnson, added:
"INLEXZO combines innovation in both pharmaceuticals and medical devices, reflecting Johnson & Johnson’s ability to accelerate therapies that bring meaningful benefits to patients."
Meri-Margaret Deoudes, CEO of the Bladder Cancer Advocacy Network (BCAN), said:
"This approval represents real progress for the bladder cancer community. Patients now have more bladder-sparing treatment options, including INLEXZO, helping them move forward with confidence and hope."
Source: prnewswire.com
