Jelmyto was evaluated across low-grade UTUC tumor types in a real-world multicenter study1
Tumor size
- Completely ablated: 43%
- <1 cm: 8.8%
- 1-3 cm: 30%
- >3 cm: 15%
Number
of tumors
- Unifocal: 51%
- 2-3 tumors: 27%
- >3 tumors: 18%
Location
- Above the UPJ: 65%
- Below the UPJ: ~9%
- Both: 26%
Multicenter real-world study: A retrospective review of patients with upper tract urothelial cancer who were treated with Jelmyto at 15 high-volume academic and community centers (N=132 patients; 136 renal units) with a focus on practice patterns, efficacy, and adverse events. Jelmyto was used in the primary chemoablative setting and following varying degrees of endoscopic management. The majority of cases were biopsy-proven low-grade upper tract urothelial cancer.1
UroGen's Olympus trial studied patients with treatment-naïve or recurrent LG-UTUC with ≥1 measurable papillary tumor 5 to ≤15 mm located above the UPJ (tumor debulking was permitted prior to study enrollment for tumors >15 mm).2
Mitomycin for pyelocalyceal solution (JELMYTO) should NOT be instilled immediately following resection or ablation.
Please refer to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)3 and the AUA/SUO Guideline for principles of instillation therapy.4
Efficacy results in a subgroup analysis of
patients with low-grade UTUC1*
Patients with no evidence of disease after JELMYTO induction (n=100)1
Tumor size prior
to induction†:
No visible
tumor‡ (n=43)
<1 cm (n=9)
1-3 cm (n=29)
>3 cm (n=16)
Median follow-up was 6.7 months following JELMYTO induction (IQR 3.5-11.3)1
Results from a longitudinal follow-up of this
real-world study5
UTUC were recurrence
free at 3 years§(n=52 renal units)5||
Recurrence patterns were consistent across
various factors, including intent to treat, route of
administration (antegrade vs retrograde), tumor
location, tumor size before induction, and
presence of multifocal disease.5
Longitudinal follow-up study: 132 patients (136 renal units) received Jelmyto induction. Of the 115 units that had an endoscopic evaluation following the treatment course, 56 showed no evidence of disease, 54 still had disease present, and 5 were indeterminate (follow-up: 6.7 months).1 This analysis of recurrence is based on the 56 renal units that did not recur following induction with Jelmyto. The median follow-up time was 23.5 months (17.4-28.0 months).5
A wider scope of upper tract urothelial cancer was treated in these studies than in the Olympus study, including patients with complete endoscopic ablation prior to Jelmyto induction, patients with larger bulky tumors, and patients with ureteral disease.1,2,5,6 These areas represent major knowledge gaps that require further exploration.
Safety data and limitations
real-world study1¶
| Ureteral stenosis** | 23% (n=27) |
| Urinary tract infection | 15% (n=20) |
| Pyelonephritis requiring hospitalization | 8.1% (n=11) |
| Other grade 3 or higher adverse events | |
| Anemia | 1.5% (n=2) |
| Acute cystitis causing sepsis | 0.7% (n=1) |
| Acute renal failure | 0.7% (n=1) |
| Failure of thrive | 0.7% (n=1) |
| Nonobstructive, nonoliguric renal failure | 0.7% (n=1) |
| Rash | 0.7% (n=1) |
| Stroke | 0.7% (n=1) |
| Shingles | 0.7% (n=1) |
| Pancytopenia | 0.7% (n=1) |
The limitations of the multicenter study and its longitudinal follow-up include the following1:
- Inevitable under-staging/undergrading due to sampling error
- Ureteral stenosis defined by clinician judgment vs objective criteria
- Short-term follow-up may underestimate risk of recurrence/progression
- Not all patients had a full induction course (ITT analysis) or reached first endoscopic evaluation
- No standardized diagnostic criteria or administration
- Variable maintenance protocols and surveillance regimen
- Potentially confounded by prior treatment
- Subset analyses are small and likely underpowered to determine recurrence patterns
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Indications and Usage
Jelmyto® (mitomycin) for pyelocalyceal solution is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC).
Important Safety Information
Contraindications
Jelmyto® (mitomycin) for pyelocalyceal solution is contraindicated in patients with perforation of the bladder or upper urinary tract.
Warnings and Precautions
Ureteric Obstruction
Ureteric obstruction, including ureteral stenosis and hydronephrosis, occurred in patients receiving Jelmyto. Monitor patients for signs and symptoms of ureteric obstruction, including flank pain, and fever, and for changes in renal function. Patients who experience obstruction may require transient or long-term ureteral stents or alternative procedures. Withhold or permanently discontinue JELMYTO based on the severity of ureteric obstruction.
Bone Marrow Suppression
The use of Jelmyto can result in bone marrow suppression, particularly thrombocytopenia and neutropenia. The following tests should be obtained prior to each treatment: Platelet count, white blood cell count differential and hemoglobin. Withhold JELMYTO for Grade 2 thrombocytopenia or neutropenia. Permanently discontinue for Grade 3 or greater thrombocytopenia or neutropenia.
Embryo-Fetal Toxicity
Based on findings in animals and mechanism of action, Jelmyto can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of mitomycin resulted in teratogenicity. Advise females of reproductive potential to use effective contraception during treatment with JELMYTO and for 6 months following the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with JELMYTO and for 3 months following the last dose.
Adverse Reactions
Common Adverse Reactions
The most common adverse reactions in ≥ 20% of patients treated with Jelmyto were ureteric obstruction, flank pain, urinary tract infection, hematuria, renal dysfunction, nausea, abdominal pain, fatigue, dysuria, and vomiting.
Additional Adverse Reactions Information
Selected clinically relevant adverse reactions in < 10% and ≥ 2% of patients who received Jelmyto include urinary tract inflammation, bladder spasm, urosepsis, hypersensitivity, and instillation site pain.
Use in Specific Populations
Lactation
Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with Jelmyto and for 1 week following the last dose.
Preparation and Administration Information
Jelmyto is for pyelocalyceal use only and not for intravenous use, topical use, or oral administration. Jelmyto must be prepared and administered by a healthcare provider. To ensure proper dosing, it is important to follow the preparation instructions found in the JELMYTO Instructions for Pharmacy and administration instructions found in the JELMYTO Instructions for Administration.
Jelmyto may discolor urine to a violet to blue color following the instillation procedure. Advise patients to avoid contact with urine for at least six hours post-instillation, to void urine sitting on a toilet, and to flush the toilet several times after use.
Jelmyto is a hazardous drug. Follow applicable special handling and disposal procedures.
Please click here for Full Prescribing Information.
References: 1. Woldu SL, Labbate C, Murray KS, et al. Early experience with UGN-101 for the treatment of upper tract urothelial cancer – a multicenter evaluation of practice patterns and outcomes. Urol Oncol. 2023;41(3):147.e15-147.e21. 2. JELMYTO [package insert]. Princeton, NJ: UroGen Pharma, Inc.; 2025. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer V.3.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed December 19, 2025. 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. 4. Coleman JA, Clark PE, Bixler BR, et al. Diagnosis and management of non-metastatic upper tract urothelial carcinoma: AUA/SUO guideline. J Urol. 2023;209(6):1071-1081. 5. Woldu SL, Igel D, Johnson B, et al. Durability of response of UGN-101: longitudinal follow up of multicenter study. Urol Oncol. 2025;43(6):391.e11-391.e20. 6. Kleinmann N, Matin SF, Pierorazio PM, et al. Primary chemoablation of low-grade upper tract urothelial carcinoma using UGN-101, a mitomycin-containing reverse thermal gel (Olympus): an open-label, single-arm, phase 3 trial. Lancet Oncol. 2020;21(6):776-785.