Managing AEs with Gemcitabine Intravesical System in NMIBC

Like all intravesical therapies, the gemcitabine intravesical system (Inlexzo), formerly TAR-200, is associated with a specific set of adverse effects (AEs), most notably urinary frequency and dysuria. Understanding and proactively managing these AEs are paramount for ensuring patient compliance and maintaining their quality of life.

Gary Steinberg, MD, a professor in the Department of Urology at Rush University, provided a look at the AE profile of the gemcitabine intravesical system. He noted that, unlike traditional instillations, the device is a foreign body that remains in the bladder, which may contribute to a different pattern of urinary symptoms.

Steinberg pointed out that the phase 2 SunRISe-1 trial (NCT04640623) data indicated a higher incidence of urinary tract symptoms with the gemcitabine intravesical system compared with some other clinical trials.

Transcript:

There’s no question that with the [gemcitabine intravesical system], it’s a foreign body that’s put in the bladder and stays there. Interestingly, for every 3-week installation of [gemcitabine], it’s only delivering the drug for one of those 3 weeks. Why you keep a foreign body when it’s only delivering a drug for 1 week out of 3 is something that needs to be investigated. There’s no question that the number of serious [AEs], about 24% with the [gemcitabine intravesical system] and a discontinuation rate of about 7%—some of the presentations were as high as 9%—is of concern. The other thing that we saw was a higher incidence of [urinary tract symptoms] with the [gemcitabine intravesical system] vs other trials. Symptoms of the urinary tract infections [include] frequency and urgency, and treating [older] patients with multiple rounds of antibiotics does lead to antibiotic resistance. Treating patients in their 70s and 80s with multiple medications or an overactive bladder does lead to other [AEs] such as dry mouth, constipation, blurry vision, and so forth. Many [older] patients don’t necessarily tolerate the overactive bladder medications very well. It is a fine line.

One of the things that I’ve been told anecdotally is that there are some, especially female patients, who will void out the [gemcitabine intravesical system]. There are some [therapy] delays and needs to have a catheter…put back in, but having a cystoscopy every 3 weeks for 6 months, and then every 6 months for up to 18 months, is something to consider.

Reference

U.S. FDA approval of INLEXZO™ (gemcitabine intravesical system) set to transform how certain bladder cancers are treated. News release. Johnson & Johnson. September 9, 2025. Accessed September 9, 2025. https://tinyurl.com/4zjz22z7