In patients with low-grade UTUC

Chemoablate with Jelmyto to deliver a complete response, while sparing the kidney for tomorrow1*

58% N=71 (95% CI: 45, 69)
84% (95% CI: 71, 97) Durability of Response. Estimated probability by KM analysis that a patient will remain in CR for 12 months<sup>2,3</sup>
    At the 12-month assessment of durability (n=41)1:
  • 23 patients remained in CR
  • 8 patients had disease recurrence
  • 10 patients were inevaluable
  • Median duration of response was not reached, with a range of 0 - 18.8+ months1
  • Patients had treatment-naïve or recurrent low-grade non-invasive UTUC with at least one measurable papillary tumor 5 to ≤ 15 mm1
  • Kaplan-Meier analysis estimates probability of durable response. It does not represent an actual percentage of patients. In the Olympus trial, at the time of the 12-month assessment for durability, not all patients had a recurrence (patients may have still been in CR, died, or discontinued). The KM analysis accounts for these missing data. The analysis has potential limitations: the sample size was small (n=41) and median duration of response was not reached due to the limited number of recurrences (n=8); this may be reflective of a short follow-up time (12 months)1

Prespecified subgroup analysis: patients with unresectable tumors

  • Nearly half (48%) of patients in the Olympus Study had endoscopically unresectable tumors, and the rate of complete response was similar among this subgroup (n=20/34)4
*Jelmyto is instilled via the pyelocalyceal system in a procedure that spares the kidney.
CI=confidence interval; KM=Kaplan-Meier analysis.

Study Design

The Olympus Study (N=71) was a phase 3, open-label, single-arm, multicenter trial in patients with treatment-naïve or recurrent low-grade UTUC with ≥ 1 measurable papillary tumor1,4

ScreeningTreatmentFollow-Up (Post-Treatment Maintenance And Evaluation)
6 once-weekly
Post-treatment evaluation
6 months
12 months

Primary endpoint: Complete response (CR)1
Secondary endpoint: Durability of response at 12-month follow-up of CR evaluation2

  • CR was defined as a complete absence of tumor lesions in the ipsilateral pyelocalyceal system at 3 months after initiation of Jelmyto by urine cytology, ureteroscopy, and biopsy (if warranted)1
  • Patients with larger tumors could have had tumor debulking prior to treatment (37% underwent tumor debulking prior to enrollment)1
  • The trial allowed for the instillation of Jelmyto into the pyelocalyceal system via ureteral catheter or nephrostomy tube1
  • Patients received Jelmyto once weekly for 6 weeks and, if assessed as a CR, for up to 11 monthly maintenance treatments1

Patient Characteristics

Jelmyto was studied in patients with varied baseline characteristics1,3

Patient Baseline Characteristics In The Olympus Study (N=71)
AgeMedian 71 yearsRange 42-87 years
Number of papillary tumorsMedian 2Range 1-8
Diameter of largest papillary tumorMedian 8 mmRange 5-15 mm
Unresectable tumors at baseline48%
Prior history of low-grade UTUC52%
  • Patients enrolled had at least one measurable papillary tumor 5 to ≤ 15 mm1
  • The median number of instillations was 6 (range 3-6)1
  • During the follow-up period, 29 patients received at least 1 dose of maintenance therapy1
Median number of papillary lesions just prior to treatment was 1 lesion (range 1-5).

Every patient deserves a chance to spare their kidney for tomorrow

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)

NCCN Guidelines® for Upper GU Tract Tumors


National Comprehensive Cancer Network® (NCCN®) recommends mitomycin for pyelocalyceal solution (Jelmyto) following complete or near complete endoscopic resection as a primary therapy option for upper tract tumors

Most suitably indicated for5:

line-art illustration of residual tumor matter

a residual, low-grade, low volume (5-15 mm), solitary tumor in the upper urinary tract

line-art illustration of residual tumor matter

a patient not a candidate for or not seeking nephroureterectomy as a definitive treatment

Mitomycin for pyelocalyceal solution may be administered via ureteral catheter or a nephrostomy tube. Complete or near complete endoscopic resection or ablation is recommended prior to mitomycin ureteral gel application.

Category 2A recommendation. Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate. All recommendations are Category 2A unless otherwise indicated.
§See NCCN Guidelines® Bladder Cancer (Version 2.2022) Intrapelvic and Intravesical Therapy for Upper Tract Tumors and NCCN Guidelines for Upper GU Tract Tumors (Version 2.2022) for detailed recommendations.
Full Prescribing InformationArrow (right) icon

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


Jelmyto is contraindicated in patients with perforation of the bladder or upper urinary tract.

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.

Common Adverse Reactions

The most common adverse reactions in ≥ 20% of patients treated with Jelmyto were ureteric obstruction, flank pain, urinary tract infection, hematuria, abdominal pain, fatigue, renal dysfunction, nausea, 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

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

Please click here for JELMYTO Full Prescribing Information, including the Patient Information, for additional information.

Please click here for Full Prescribing Information, Instructions for Pharmacy, and Instructions for Administration.

References: 1. JELMYTO [package insert]. Princeton, NJ: UroGen Pharma, Inc.; 2022. 2. Matin SF, Pierorazio PM, Kleinmann N, et al. Durability of response to primary chemoablation of low-grade upper tract urothelial carcinoma using UGN-101, a mitomycin-containing reverse thermal gel: OLYMPUS trial final report. J Urol. 2022;207(4):779-788. 3. Rouprêt M, Babjuk M, Burger M, et al. European Association of Urology guidelines on upper urinary tract urothelial carcinoma: 2020 update. Eur Urol. 2021;79(1):62-79. 4. 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. 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer V.2.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed May 20, 2022. To view the most recent and complete version of the guidelines, go online to 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.