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

Dichotomous primary endpoint:
Complete response (CR) vs no CR2


of patients achieved CR
with Jelmyto

N=71 (95% CI: 45, 69)

  • As OLYMPUS was a single-arm trial intended to demonstrate the effect of chemoablation, patients had to have a remaining index lesion for inclusion criteria1
  • Patients had treatment-naïve or recurrent low-grade noninvasive UTUC with at least one measurable papillary tumor 5 to ≤ 15 mm1

Prespecified subgroup analysis: Patients with unresectable tumors3

  • 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)
JELMYTO is instilled via the pyelocalyceal system in a procedure that spares the kidney.
Forty-two patients achieved CR at primary disease evaluation; however, one patient withdrew consent.3
Emergence of high-grade disease (not detected at baseline).2
Defined as any increase in tumor size or number that was not a complete response.3

In patients with low-grade UTUC,

Complete response with JELMYTO has proven durable over time1,4

Duration of response (DoR) was assessed at 12 months

Olympus Study1

  • 23 (56%) patients remained in CR
  • 8 patients had disease recurrence
  • 10 patients were inevaluable

Median DoR was not reached (range 0-18.8+ months)

A separate noninterventional study4

Long-term outcomes in eligible patients previously enrolled in the Olympus Study

Long-term follow-up study||

In a subset of 16 patients who had previously achieved CR at the Olympus 12-month assessment

  • 29 months median DoR (range 14.6-47.6 months)
    • 81% (n=13/16) continued CR beyond 12 months
    • 2 patients had a recurrence
    • 1 patient had an RNU following ureteral stricture
Long-term follow-up study: Interim results from an ongoing rollover study. The primary objective was to obtain long-term results from participating patients in the Olympus Study, including those who had achieved CR at the 12-month assessment of durability. This study is in accordance with UroGen's postmarketing commitment to provide annual updates for consenting patients with ongoing CR who were enrolled in the Olympus Study.4

The limitations of this study and the DoR analysis include the following: (1) The sample size of the subpopulation for the DoR analysis was small (n=16); (2) This study did not enroll nor follow 7 of the 23 patients (30%) who had remained in CR at the end of the OLYMPUS Study; (3) The methodology for evaluating patient outcomes differed from the one used in the Olympus trial.4

RNU = radical nephroureterectomy.

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Real-world study

Jelmyto was studied in a heterogeneous, real-world population in Urologic Oncology

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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.

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. Data on file. UroGen Pharma, Inc., Princeton, NJ. 3. 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. 4. Pierorazio PM, Kleinmann N, Shabsigh A, et al. Long-term outcomes of treatment with UGN-101, a mitomycin-containing reverse thermal gel, for primary chemoablation of low-grade upper tract urothelial carcinoma (LG UTUC). Poster presented at: Annual Meeting of the Society of Urologic Oncology; November 30-December 2, 2022; San Diego, CA. Poster 158.