SUMMARY

• INLEXZO (gemcitabine intravesical system) is an intravesical drug releasing system (iDRS), referred to as TAR-200 in literature.¹ 
• INLEXZO is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.²
• SunRISe-1 (NCT04640623) is an ongoing, phase 2b, randomized, open-label, parallel-cohort, multicenter study evaluating the efficacy and safety of intravesical INLEXZO plus  systemic cetrelimab, an investigational immunoglobulin G4 (IgG4) antibody that targets the programmed cell death protein-1 (PD-1) receptor (cohort 1), INLEXZO monotherapy (cohort 2), or cetrelimab monotherapy (cohort 3) in patients with BCG-unresponsive high-risk NMIBC who are ineligible for or decline radical cystectomy (RC). INLEXZO monotherapy is additionally being studied in patients with papillary-only BCG-unresponsive high-risk NMIBC (no CIS; cohort 4).^1,3
  • Of the patients given INLEXZO monotherapy (cohort 2; n=85), the median age was 71.0 (range, 40-88).¹ 

Product labeling

• INLEXZO (gemcitabine intravesical system) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/INLEXZO-pi.pdf.
• INLEXZO (gemcitabine intravesical system) [Instructions for Use]. Horsham, PA: Janssen Biotech, Inc; https://www.janssenlabels.com/package-insert/product-instructions-for-use/INLEXZO-ifu.pdf.

The results of the SunRISe-1 study are also included in the INLEXZO product labeling. The total number of patients given INLEXZO monotherapy described above may vary from that in the INLEXZO product labeling due to the evaluation of different patient populations for efficacy and safety analyses. 

Section 8.5 Geriatric Use

• Of the patients given INLEXZO monotherapy in Cohort 2 of SunRISe-1 (n=83), 72% were 65 years of age or older and 34% were 75 years or older. There were insufficient numbers of patients <65 years of age to determine if these patients respond differently to patients 65 years of age and older.²  

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 22 August 2025.