INLEXZO™ is a groundbreaking drug releasing system that provides prolonged local delivery of gemcitabine into the bladder1-3
Powerful complete and durable response1
Complete response
(CR) rate*
82%(68/83)
(95% CI, 72%-90%)
DURABLE
RESPONSE†
51%(35/68) of patients
maintained a CR ≥12 months
(range: 0-44+ months)
Safety Profile (N=85) for INLEXZO™1
Serious adverse reactions (ARs) occurred in 24% of patients receiving INLEXZO™. Serious ARs that occurred in >2% of patients included urinary tract infection (UTI), hematuria, pneumonia, and urinary tract pain.
Fatal ARs occurred in 1.2% of patients (n=1) who received INLEXZO™, including cognitive disorder.
The most common adverse reactions (ARs) (all grades; >15%) included:
- Urinary frequency (48%)
- UTI (44%)
- Dysuria (42%)
- Micturition urgency (34%)
- Urinary tract pain (26%)
- Hematuria (24%)
- Bladder irritation (16%)
Select laboratory abnormalities (all grades; >15%) that worsened from baseline in patients who received INLEXZO™ in SunRISe-1 included‡:
- Decreased hemoglobin (31%)
- Increased lipase (28%)
- Decreased lymphocytes (24%)
- Increased creatinine (24%)
- Increased potassium (22%)
- Increased AST (17%)
- Decreased sodium (16%)
- Increased ALT (16%)
Study Design1
INLEXZO™ was evaluated in Cohort 2 of SunRISe-1, a single-arm, multi-center study of patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors (T1 or high-grade Ta) following transurethral resection. The major efficacy outcome measures were CR rate at any time and duration of response (DoR).
Patients received INLEXZO™ (225 mg of gemcitabine) into the bladder every 3 weeks for 6 months, followed by once every 12 weeks for up to 18 months, or until unacceptable toxicity, persistence or recurrence of CIS and/or high-grade papillary disease, or progression.
*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.1,4
‡The denominator used to calculate the rate varied from 82 to 83 based on the number of patients with a baseline value and at least one posttreatment value.1
Review the full Prescribing Information
and Instructions for Use for INLEXZO™
Extended Payment Terms
To help mitigate any potential provider reimbursement delays prior to permanent J-code assignment, up to 120-day extended payment terms for INLEXZO™ may be available from your Authorized Specialty Distributor. Actual payment terms are determined by your Authorized Specialty Distributor. Please reach out to your Authorized Specialty Distributor for more details.
Access the How to Order Guide—
with key instructions for ordering INLEXZO™
A comprehensive resource to help navigate coverage and
reimbursement, supporting patient access to INLEXZO™
Watch the Procedural Video for INLEXZO™
This video explains the preparation, insertion, removal, and disposal of INLEXZO™
References: 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. 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 September 2, 2025. https://ascopubs.org/doi/suppl/10.1200/JCO-25-01651/suppl_file/protocol1_JCO-25-01651.pdf