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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 in Patients with Hepatic Impairment

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 
  • Johnson & Johnson does not recommend any practices, procedures or usage that deviate from the product labeling or are not approved by the regulatory agencies.
  • 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
    • Any potential patient who met any of the following criteria were excluded from participating in the study:
      • Patients must not have clinically significant liver disease that precludes patient treatment regimens prescribed on the study (including, but not limited to active viral, alcoholic, or other autoimmune hepatitis, cirrhosis, or inherited liver disease).3 
      • Patients with active hepatitis B or C infection (patients with history of hepatitis C infection but undetectable hepatitis C virus polymerase chain reaction [PCR] test and patients with history of hepatitis B infection with positive hepatitis B surface antigen [HBsAg] antibody and undetectable PCR are allowed).2,3 

Product labeling

Literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 22 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 22]. 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.