SUMMARY

• Johnson & Johnson does not recommend any practices, procedures or usage that deviate from the product labeling or are not approved by the regulatory agencies.
• INLEXZO (gemcitabine intravesical system) is an intravesical drug releasing system (iDRS), referred to as TAR-200 in literature.¹ 
• 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 (investigational IgG4 antibody targeting PD-1 receptor; cohort 1), INLEXZO monotherapy (cohort 2), or cetrelimab monotherapy (cohort 3) in patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary disease who are ineligible for or decline radical cystectomy (RC). INLEXZO monotherapy is additionally being studied in patients with BCG-unresponsive papillary-only high-risk NMIBC (no CIS; cohort 4).^1,2
  • Patients enrolled in the study were required to have adequate renal function defined as creatinine clearance ≥30 mL/min calculated using Cockcroft-Gault formula.³ 
  • No data has been separately reported in patients with renal impairment.

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.

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.