UroGen Pharma Receives U.S. FDA Expedited Approval for Jelmyto?, the First and Only Non-Surgical Treatment for Patients with Low-Grade Upper Tract Urothelial Cancer
- Approval Based on Phase 3 Trial Results Showing a Complete Response Rate of 58%
- Median Duration of Response Has Not Been Reached
- Therapy Provides an Effective, Kidney-Sparing Option for Patients With This Rare and Difficult-To-Treat Cancer
- First-in-Class Approval Validates UroGen?s Innovative Technology and Future Opportunity Across its Specialty Cancers and Urologic Diseases Portfolio
- Company to Host Conference Call on?Thursday, April 16?at?8:30 AM Eastern Time
- Complete response (CR) (primary endpoint) of 58% in the intent-to-treat population and in the sub-population of patients who were deemed not capable of surgical removal at diagnosis.
- At the 12-month time point for assessment of durability, 19 patients remained in CR, seven had experienced recurrence of disease and nine patients continued to be followed for the 12-month duration of response.
- Kaplan-Meier analysis estimated 12-month durability at 84%2?(based on interim data).
- The most commonly reported adverse events (= 20%) were ureteric obstruction, flank pain, urinary tract infection, hematuria, renal dysfunction, fatigue, nausea, abdominal pain, dysuria, and vomiting. Most adverse events were mild to moderate and manageable using well established treatments. No treatment-related deaths occurred.
- are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO. Females who are able to become pregnant:?You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose. Males being treated with JELMYTO:?If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.
- are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.
- Tell your healthcare provider if you take water pills (diuretic).
- Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.
- You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider?s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.
- JELMYTO is given to your kidney through a tube called a catheter.
- During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
- JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.
- To urinate,?males and females should sit?on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.
- Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
- Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction).?If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.
- Bone marrow problems.?JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.
- Browne BM, Stensland KD, Moynihan MJ, Canes D. An Analysis of Staging and Treatment Trends for Upper Tract Urothelial Carcinoma in the National Cancer Database. Clin Genitourin Cancer 2018;16:e743-e50.
- Lerner, Seth. Primary Chemoablation for the treatment of Low-Grade Upper Tract Urothelial Carcinoma: The Olympus Trial. 2020 by?American Urological Association Education and Research, Inc.
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INVESTOR CONTACT: Kate Bechtold Senior Director, Investor Relations Kate.Bechtold@urogen.com 914-552-0456 MEDIA CONTACT: Eric Van Zanten Senior Director, Communications Eric.VanZanten@urogen.com 610-529-6219 Source:?UroGen Pharma Ltd.