The U.S. Food and Drug Administration (FDA) has approved the gemcitabine intravesical system (Inlexzo) for adults with bacillus Calmette-Guérin (BCG)-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors. The gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder.
SunRISe-1
Efficacy was evaluated in cohort 2 of SunRISe-1 (CinicalTrials.gov identifier NCT04640623), a single-arm, multicenter trial that enrolled 83 patients with BCG-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors following transurethral resection (TURBT). Patients received the gemcitabine intravesical system into the bladder every 3 weeks for 6 months, followed by once every 12 weeks for up to 18 months.
Tumor status was assessed with cystoscopy and urine cytology every 12 weeks during the initial 2 years of treatment, after which cystoscopy was performed at least every 24 weeks. Mandatory biopsies were performed at 24 and 48 weeks after treatment initiation.
The major efficacy outcome measures were complete response at any time (defined as negative results for cystoscopy [with TURBT/biopsies as applicable] and urine cytology) and duration of response. Complete response assessment at each timepoint was based on central pathology review.
The complete response rate was 82% (95% confidence interval = 72%–90%); 51% of patients with a complete response had a duration of response lasting at least 12 months.
The prescribing information includes warnings and precautions describing risks of administering the gemcitabine intravesical system in patients with a perforated bladder, metastatic bladder cancer with delayed cystectomy, magnetic resonance imaging safety, and embryofetal toxicity.
The gemcitabine intravesical system delivers 225 mg of gemcitabine into the bladder, with an indwelling period following each insertion of 3 weeks prior to its removal. The gemcitabine intravesical system is inserted once every 3 weeks for up to 6 months (eight doses), followed by once every 12 weeks for up to 18 months (six doses), or until persistent or recurrent high-grade non–muscle-invasive bladder cancer, disease progression, or unacceptable toxicity.
This review used the Real-Time Oncology Review pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
This application was granted Priority Review. The gemcitabine intravesical system received Breakthrough Therapy designation.
