The U.S. Food and Drug Administration has granted approval to Johnson & Johnson’s drug delivery system for a specific type of bladder cancer. The decision allows the company to introduce Inlexzo, a system designed to provide a surgery-free pathway for patients requiring advanced therapy.
The newly approved Inlexzo bladder cancer treatment is intended for individuals diagnosed with high-risk non-muscle invasive bladder cancer who did not benefit from Bacillus Calmette-Guerin therapy, which remains the standard of care. It is also targeted at patients who are either unsuitable for bladder removal surgery or have chosen not to undergo the procedure.
“We believe Inlexzo represents a unique bladder-sparing treatment that addresses a significant unmet need for patients who have limited options after unsuccessful BCG therapy,” said Guggenheim analyst Vamil Divan.
The FDA’s decision relied on data gathered from a mid-stage clinical trial. In this study, more than 82% of participants who received the Inlexzo bladder cancer treatment showed no visible signs of cancer following therapy. Additionally, over half of these patients were able to maintain remission for at least one year, demonstrating encouraging durability in outcomes.
“This drug, at ultra low doses for long periods of time… behaves in a way that not only pushes the disease into remission, but then maintains it through some immune memory,” noted Christopher Cutie, vice president and disease area leader for bladder cancer at Johnson & Johnson, in comments made prior to the FDA decision.
According to Johnson & Johnson, the treatment involves inserting Inlexzo directly into the bladder, where it remains for three weeks in each treatment cycle. Patients can undergo up to 14 such cycles. Importantly, the system is designed not to disrupt day-to-day activities while steadily releasing the chemotherapy drug gemcitabine into the bladder.
The company noted that the most common side effects linked with the therapy include urinary frequency, urinary tract infections, and pain. Johnson & Johnson added that the therapy was originally acquired in 2019, when the firm purchased biotechnology company TARIS Biomedical.
Inlexzo is also undergoing additional clinical evaluation in patients with muscle-invasive bladder cancer, further extending its potential role in oncology and broader healthcare innovation.
