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INLEXZO™

(gemcitabine intravesical system)

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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

INLEXZO™ (gemcitabine intravesical system)

Medical Information

INLEXZO – Use of INLEXZO in Combination with Docetaxel

Last Updated: 09/10/2025

SUMMARY

  • INLEXZO (gemcitabine intravesical system) is an intravesical drug releasing system (iDRS), referred to as TAR-200 in literature.1 
  • No prospective, randomized trials have been reported to evaluate the efficacy and safety of INLEXZO use in combination with docetaxel.
  • SunRISe-1 (NCT04640623) is an ongoing, phase 2b, randomized, open-label, 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 Bacillus Calmette-Guérin (BCG)-unresponsive high-risk, non-muscle invasive bladder cancer (NMIBC) who are ineligible for or decline radical cystectomy (RC). INLEXZO monotherapy is additionally being studied in patients with papillary-only BCG-unresponsive HR-NMIBC (no CIS; cohort 4).1,2   
    • Concurrent use of anti-neoplastic agents (eg, chemotherapy) was prohibited during the study.3 

Product labeling

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 19 August 2025.

 

References

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1 Daneshmand S, Van der Heijden MS, Jacob JM, et al. TAR-200 for Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer: results from the phase IIb SunRISe-1 study. [published online ahead of print July 30, 2025]. J Clin Oncol. doi:10.1200/jco-25-01651.  
2 Janssen Research & Development, LLC. Phase 2b clinical study evaluating efficacy and safety of TAR-200 in combination with cetrelimab, TAR-200 alone, or cetrelimab alone in participants with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to intravesical Bacillus Calmette-Guérin (BCG) who are ineligible for or elected not to undergo radical cystectomy. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 August 19]. Available from: https://clinicaltrials.gov/show/NCT04640623 NLM Identifier: NCT04640623.  
3 Daneshmand S, van der Hejiden MS, Jacob JM, et al. Clinical protocol for: TAR-200 for Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer: results from the phase IIb SunRISe-1 study. [published online ahead of print July 30, 2025]. J Clin Oncol. doi:10.1200/jco-25-01651.