New CMS J-Code Set to Enhance Adoption of Mitomycin Therapy for Recurrent LG-IR-NMIBC

The Centers for Medicare & Medicaid Services (CMS) issued a permanent J-code (J9282) for ZUSDURI, an intravesical mitomycin treatment for recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC), effective January 1, 2026. This change streamlines billing and is expected to improve patient access to a therapy that showed strong response rates in its Phase 3 trial.

ZUSDURI^TM Profile & Mechanism

• Manufacturer: UroGen Pharma Ltd.
• Mechanism of Action: Cell death induced by inhibition of DNA synthesis through cross-linking
• Novel Delivery System: Non-surgical intravesical solution (56 mL) that delivers 75 mg mitomycin directly into the bladder via sustained-release RTGel technology
  • RTGel technology enables mitomycin administration via catheter as a liquid, which then transforms into a semi-solid gel
• Treatment Schedule: Once-weekly (6 consecutive weeks)
• Target Population: Adults with LG-IR-NMIBC

Approval Details

• Approval Pathway: Based on results from a single-arm, multicenter, Phase 3 ENVISION (NCT05243550) trial (n=240)
  • The trial remains ongoing, with final completion anticipated in February 2028
• Complete Response Rate: 78% (95% CI: 72, 83) at 3 months following the first dose of the therapy
• Duration of Response: 79% of complete responders maintained response ≥12 months
• Tumor Assessment: Cystoscopy, for-cause biopsy, and urine cytology (every 3 months)

Safety Profile

• Exclusion Criteria: Perforation of the bladder and/or allergic reaction to mitomycin or any ZUSDURI ingredients
• Common Adverse Events (≥10%): Increased creatinine, potassium, aspartate aminotransferase, alanine aminotransferase, eosinophils; decreased hemoglobin, lymphocytes, or neutrophils; and occurrences of urinary tract infection, dysuria, or hematuria
• Serious Adverse Reactions (12%): Urinary retention (0.8%) and urethral stenosis (0.4%)

Development Status & Next Steps

• Current ZUSDURI status: Approved June 12, 2025 and commercially available
• Prescribing information: Available at accessdata.fda.gov
• Safety monitoring: Key warnings include perforated bladder contraindication and embryo-fetal toxicity
• Side Effect Reporting: Patients are encouraged to report negative side effects to the FDA

Sources:

“A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (ENVISION).” Clinicaltrials.gov, 4 Nov. 2024, clinicaltrials.gov/study/NCT05243550. Accessed 1 Dec. 2025.

Clarke, Hannah. “CMS Issues Permanent J Code for Mitomycin for Intravesical Solution for LG-IR-NMIBC.” Urologytimes.com, Urology Times, 27 Oct. 2025, www.urologytimes.com/view/cms-issues-permanent-j-code-for-mitomycin-for-intravesical-solution-for-lg-ir-nmibc. Accessed 1 Dec. 2025.

“FDA Approves Mitomycin Intravesical Solution for Recurrent Low-Grade.” U.S. Food and Drug Administration, 12 June 2025, www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle. Accessed 1 Dec. 2025.

Feldman, Spencer. “Zusduri Shows Durable Response in Non–Muscle-Invasive Bladder Cancer.” Curetoday.com, CURE, 7 Aug. 2025, www.curetoday.com/view/zusduri-shows-durable-response-in-non-muscle-invasive-bladder-cancer. Accessed 1 Dec. 2025.