Johnson & Johnson Receives FDA approval for INLEXZO™ in bladder cancer
Wednesday, September 10, 2025
Johnson & Johnson has received approval from the United States Food and Drug Administration (FDA) for INLEXZO™ (gemcitabine intravesical system), a new treatment for adults with non-muscle invasive bladder cancer (NMIBC) that has not responded to Bacillus Calmette-Guérin (BCG) therapy.
INLEXZO™, previously known as TAR-200, is the first intravesical drug-releasing system (iDRS) to provide extended local delivery of gemcitabine directly into the bladder. It is designed to remain in place for three weeks per treatment cycle, for up to 14 cycles. The device is inserted by a healthcare professional in an outpatient setting within a few minutes, without the need for general anaesthesia or extended monitoring.
INLEXZO™ is intended for patients seeking bladder-preserving treatment. It has been granted Breakthrough Therapy Designation, Real-Time Oncology Review and Priority Review by the FDA, reflecting its potential to address an unmet medical need.
Non-muscle invasive bladder cancer represents a significant portion of bladder cancer cases and often affects older adults. While BCG remains the standard treatment, many patients eventually become unresponsive. Radical cystectomy, the removal of the bladder, is currently recommended in such cases, but it carries high risks and impacts quality of life.
The therapy also offers an option for patients unwilling or unable to undergo bladder removal surgery.
The approval is based on findings from the Phase 2b SunRISe-1 trial (NCT04640623). Results showed that 82 per cent of patients achieved a complete response, meaning no signs of cancer were detected after treatment. Among these patients, 51 per cent maintained their response for at least one year.
The most commonly reported side effects included urinary frequency, urinary tract infections, painful urination, urgency, bladder irritation, blood in urine, and certain laboratory abnormalities such as changes in kidney and liver function markers.
With the FDA’s approval, Johnson & Johnson will provide patient support through its J&J withMe programme, offering cost support, dedicated care navigation and educational resources.
Source: jnj.com
