INLEXZO is a groundbreaking intravesical drug releasing system that releases gemcitabine directly into the bladder over the course of 3 weeks1-3
Of the total gemcitabine dose, 77% was excreted by Day 7 and 99% was excreted by Day 21 in urine as gemcitabine and dFdU1
SCROLL FOR THE STORY
STUDY DESIGN1
The efficacy and safety of INLEXZO were evaluated in Cohort 2 of SunRISe-1, a single-arm, multi-center study in adults with BCG-unresponsive NMIBC with CIS, with or without papillary tumors (T1 or high-grade Ta) following transurethral resection. The major efficacy outcome measures were complete response (CR) rate at any time and duration of response (DoR).
Powerful
CR RATE1*
82%
(68/83) (95% CI, 72%–90%) CR was achieved
without reinduction4†‡
DURABLE RESPONSE1‡†
51%
(35/68) of patients maintained
a CR ≥12 months(range: 0–44+ months)
PROVEN SAFETY1§
A familiar safety profile for urologists: The 2 most common ARs were urinary frequency (48%) and urinary tract infection (44%)1,5
24% of patients had a serious AR1
7%
of patients permanently discontinued due to ARs1
41%
of patients experienced dosage interruptions due to ARs1
*CR rate at any time was defined as negative results for cystoscopy (with transurethral resection of bladder tumor [TURBT] and centrally reviewed biopsies as applicable) and centrally reviewed urine cytology.1
†Based on patients (n=68) that achieved a CR at any time. DoR was defined from the time of first CR achieved to first evidence of recurrence, progression, or death due to any cause (whichever was earlier) for participants who achieved a CR.1,6
‡Reinduction was not included in the study design.4
§Safety population: N=85.1
*CR rate at any time was defined as negative results for cystoscopy (with transurethral resection of bladder tumor [TURBT] and centrally reviewed biopsies as applicable) and centrally reviewed urine cytology.1
†Reinduction was not included in the study design.4
‡Based on patients (n=68) that achieved a CR at any time. DoR was defined from the time of first CR achieved to first evidence of recurrence, progression, or death due to any cause (whichever was earlier) for participants who achieved a CR.1,6
§Safety population: N=85.1
Persistent
INLEXZO releases gemcitabine directly into the bladder over the course of 3 weeks1-3
Of the total gemcitabine dose, 77% was excreted by Day 7 and 99% was excreted by Day 21 in urine as gemcitabine and dFdU1
PRACTICE-READY
Practice-Ready
Familiar, in-office procedures: catheterization and cystoscopy7
Off-the-shelf storage with no refrigeration, thawing, or special preparation1∥
BCG, Bacillus Calmette–Guérin; CIS, carcinoma in situ; dFdU, difluorodeoxyuridine.
∥INLEXZO does not require freezing, refrigeration, reconstitution, or use of a hood for preparation.1
Watch the Procedural Video
for INLEXZO
This video explains the preparation, insertion, removal, and disposal of INLEXZO
NCCN
CATEGORY 2A
Gemcitabine intravesical system (INLEXZO) is guideline recommended8
Gemcitabine intravesical system (INLEXZO) is the first and only intravesical system included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a Category 2A treatment option¶ for patients with BCG-unresponsive NMIBC with CIS, with or without Ta/T1 papillary tumors.
NCCN, National Comprehensive Cancer Network® (NCCN®).
¶An NCCN Category 2A recommendation is based upon lower-level evidence with uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate.8
Consider choosing INLEXZO first after BCG for your appropriate patients with NMIBC
ABOUT INLEXZOReferences: 1. INLEXZO™ [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc. 3. Palugan L, Cerea M, Cirilli M, et al. Intravesical drug delivery approaches for improved therapy of urinary bladder diseases. Int J Pharm X. 2021;3:100100. doi:10.1016/j.ijpx.2021.100100 4. Jacob JM, Guerrero-Ramos F, Necchi A, et al. TAR-200 monotherapy in patients with bacillus Calmette–Guérin–unresponsive high-risk non–muscle-invasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcomes from SunRISe-1. Presented at: 120th American Urological Association Annual Meeting; April 26-29, 2025; Las Vegas, NV. 5. Pradere B, Schuit M, Guerrero-Ramos F, et al. Side effect management and procedural best practices with indwelling intravesical drug-releasing systems in the treatment of bladder cancer: recommendations from expert panels. Curr Opin Urol. 2026;36(1):123–133. doi:10.1097/MOU.0000000000001350 6. 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-Guerin (BCG) who are ineligible for or elected not to undergo radical cystectomy. October 4, 2024. Accessed June 3, 2026. https://ascopubs.org/action/downloadSupplement?doi=10.1200/JCO-25-01651&file=protocol_JCO-25-01651_SAP.pdf 7. INLEXZO™ [Instructions for Use]. Horsham, PA: Janssen Biotech, Inc. 8. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer V.3.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed August 11, 2026. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.