In a conversation with CancerNetwork® following the FDA approval of the gemcitabine intravesical system (Inlexzo; formerly TAR-200) for patients with high-risk, Bacillus Calmette-Guérin (BCG)–unresponsive non–muscle-invasive bladder cancer (NMIBC), Gary Steinberg, MD, discussed how this regulatory decision may impact the treatment paradigm.

Steinberg, a professor in the Department of Urology at Rush University, highlighted an unmet need for those with BCG-unresponsive, high-grade NMIBC. With a different mechanism of action compared with prior therapeutic choices in the field, he stated that the gemcitabine intravesical system may allow patients and physicians to benefit tremendously. Based on supporting data from the phase 2 SunRISe-1 trial (NCT04640623), he described how the gemcitabine intravesical system may replace prior standards such as intravesical gemcitabine plus docetaxel.

The conversation also touched upon considerations for preventing the risk of progression to metastatic disease with delayed cystectomy, as Steinberg emphasized following up with patients via cystoscopies, urinary cytologies, CT scans, or MRI imaging after treatment with the intravesical system. Steinberg also detailed strategies for mitigating urinary frequency, dysuria, and other toxicities associated with the therapy. He noted a “fine line” regarding bladder medication administration to older patient populations, as these practices may cause adverse effects such as dry mouth, constipation, and blurry vision.

Looking ahead, Steinberg illustrated a need to clarify the immunologic effects of regimens like the gemcitabine intravesical system, which can inform the use of additional therapeutic combinations down the road. He highlighted how other novel agents like cretostimogene grenadenorepvec (CG0070) may further improve outcomes in the NMIBC landscape.

“One of the key questions that we all need to ask with all our treatments is not about the patients who respond, but about the patients who do not respond,” Steingerg stated regarding the potential next steps for research. “We can begin to understand mechanisms of resistance so that we can target those mechanisms of resistance and treat them better.”

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 22, 2025. https://tinyurl.com/4zjz22z7