Maintaining Hope While Navigating a Rare and Complex Urinary Cancer

(BPT) - At age 76, Jim Mulligan considered himself lucky as he had been healthy for most of his life - he was active and enjoyed traveling. After returning from a trip to Ireland with his wife, he wasn’t feeling well and went in for a simple checkup, including a scan. Jim didn't think much of it until he received a call from his doctor: he had cancer.

"I was shocked," says Mulligan, now 84. "They said I had cancer and my kidney would have to be removed."

Mulligan learned he had low-grade upper tract urothelial cancer (LG-UTUC), a rare and difficult-to-treat cancer in the lining of the ureter and kidney.¹ He wanted to know more and asked for a second opinion. The information he received ended up changing his life.

Urological health should be a priority

UTUC is hard to treat due to the complex anatomy of the urinary tract system. Current patient treatments can include multiple surgeries, with most patients requiring a nephroureterectomy, which removes the renal pelvis, kidney, ureter and bladder cuff. Many patients with UTUC are older and may have co-morbidities, or the presence of multiple chronic conditions or diseases, so surgery may not be the ideal option.¹

LG-UTUC is usually not as aggressive and can be slow to spread, but it is still a serious condition that can worsen if left untreated. A majority of the UTUC patient population may already have compromised kidney functionality and suffer from long-term issues associated with surgery and the loss of their kidney.^2,3

September is Urology Awareness Month, an important time to consider proper urological health and associated risk factors. However, people like Jim prove that urological health should be a priority all year long and to always talk to your doctor about your options.

A kidney-sparing option

After being told that he would have to have his kidney removed, Jim overcame his fear, did his own research and sought a second opinion. He met with Dr. John Gore, Professor, Department of Urology at the University of Washington School of Medicine, and an investigator of the OLYMPUS clinical trial. During his visit he learned that his LG-UTUC would potentially spread slowly. Even more important, he learned that he may not have to remove his kidney because an investigational treatment was available through the OLYMPUS clinical trial.

"We removed Jim's cancer and had him return at three and six months," says Gore, who has now been Jim’s doctor for nearly a decade. "At the six-month checkup we saw the cancer had returned, which is unfortunately common with UTUC, so I suggested he participate in the clinical trial. This trial used an investigational treatment that is a combination of chemotherapy and an innovative gel technology that is a liquid when chilled and turns into a gel at body temperature. But unlike typical chemotherapy that goes everywhere in the body, this treatment targets the affected kidney region for an extended period of time, helping spare the kidney while being treated for cancer.”

At the time of the clinical trial, Jim received the investigational treatment that is now called Jelmyto^® (mitomycin) for pyelocalyceal solution, the first and only U.S. FDA-approved non-surgical treatment for adult patients with LG-UTUC, which treated his cancer without surgery and allowed him to keep his kidney. Jim had a complete response, meaning he is cancer-free after his treatment, and feels fortunate to still have his kidney.

This is the story of one cancer patient’s experience with Jelmyto^® (mitomycin) for pyelocalyceal solution. Not all patient experiences will be the same.

How Jelmyto works and what to expect

Jelmyto is a non-surgical treatment approach for patients who otherwise may require treatment by radical nephroureterectomy, or removal of the kidney. Unlike typical chemotherapy that goes everywhere in the body, Jelmyto targets the affected region where the tumors are located. Once there, Jelmyto stays in place for up to 4 to 6 hours, enabling longer exposure to the urinary tract tissue, and in turn, the treatment of cancerous tumors.

The most common side effects of Jelmyto treatment include: side pain, urinary tract infection, blood in your urine, kidney problems, tiredness, nausea, stomach pain, trouble with urination, vomiting, low red blood cell count, frequent urination, itching, chills and fever. As with all prescription medications, there are serious side effects that may occur. These include, but are not limited to, uretic obstruction and bone marrow problems. Please contact your physician right away if you experience any symptoms.

See Important Safety Information below; these are not all possible side effects. Talk to your healthcare provider for more information.

Being an advocate for your own health

Jim is now an advocate for the urology community and shares his experience with others diagnosed with LG-UTUC. His advice: "Do research. Get a second opinion. It's important to stay informed and understand that kidney removal may not be your only option. Having multiple experts weigh in is the best way to determine the right course of action for you."

Approved Use for JELMYTO

JELMYTO^® is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

IMPORTANT SAFETY INFORMATION

You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:

• 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).

How will I receive JELMYTO?

• 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.

After receiving JELMYTO:

• 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.

JELMYTO may cause serious side effects, including:

• 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.

The most common side effects of JELMYTO include: side pain, urinary tract infection, blood in your urine, kidney problems, tiredness, nausea, stomach pain, trouble with urination, vomiting, low red blood cell count, frequent urination, itching, chills, and fever.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch 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, or visit www.jelmyto.com.

References

1. Szarvas, Tibor et al. “Why are upper tract urothelial carcinoma two different diseases?” Transl Androl Urol. vol. 5,5 (2016): 636-647. doi:10.21037/tau.2016.03.23
2. Raman JD, Lin YK, Kaag M, et al. “High rates of advanced disease, complications, and decline of renal function after radical nephroureterectomy.” Urol Oncol. 2014;32(1):47.e9-14.
3. Kaag MG, O’Malley RL, O’Malley P, Raman JD. “Changes in renal function following nephroureterectomy may affect the use of perioperative chemotherapy.” Eur Urol. 2010;58:(4)581-587.

US-JEL-00254 08/2020