Vignesh T. Packiam, MD

Panelists discuss how the promising approval of the gemcitabine intravesical system will likely drive future research into drug-device combinations for sustained drug delivery across various bladder cancer populations, including Bacillus Calmette-Guérin (BCG)-naive patients during shortages and muscle-invasive disease, potentially transforming localized bladder treatment approaches over the next decade.

Panelists discuss how practical implementation of the gemcitabine intravesical system requires integrating cystoscopic procedures into urology clinic workflows, training providers (including advanced practice providers) for device placement and removal, and developing effective patient counseling strategies for managing a 3-week indwelling device with proper tracking systems.

Panelists discuss how the gemcitabine-releasing system fits into the non–muscle-invasive bladder cancer (NMIBC) treatment algorithm by offering patients a promising intravesical option with excellent response rates and durability, though sequencing decisions must consider patient logistics, treatment availability, and individual preferences while potentially reducing but not eliminating the need for radical cystectomy.

Panelists discuss how the SunRISe-1 trial demonstrated impressive efficacy with an 82% complete response rate and 26-month median duration of response in Bacillus Calmette-Guérin (BCG)-unresponsive patients, significantly outperforming other FDA-approved therapies while maintaining a favorable safety profile with mostly minor voiding symptoms and only 13% grade 3+ adverse events.

Panelists discuss how the FDA-approved gemcitabine intravesical system (Inlexzo/TAR-200) represents a breakthrough in Bacillus Calmette-Guérin (BCG)-unresponsive bladder cancer treatment through its unique continuous drug delivery mechanism that provides sustained release over 3 weeks, requiring only 10% of traditional gemcitabine dosing while improving patient convenience and potentially reducing adverse effects.

Vignesh T. Packiam, MD, outlines the mechanism of action for detalimogene voraplasmid as well as its potential benefits in terms of storage and dosing.

"At the end of the day, it's going to be unlikely that we're going to use a single therapy for all of our patients," says Vignesh T. Packiam, MD.

"An alternative off-label option for patients with BCG-unresponsive NMIBC is sequential intravesical gemcitabine and docetaxel (Gem/Doce)," write Rachel Passarelli, MD, and Vignesh T. Packiam, MD.