The Study Results are Published in the Journal of Urology
Online
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated
to developing and commercializing novel solutions that treat
urothelial and specialty cancers, today highlights results from a
long-term follow-up study with JELMYTO (mitomycin) for
pyelocalyceal solution, which is FDA approved for the treatment of
low-grade, upper tract urothelial cancer (LG-UTUC) in adult
patients. Among patients from the OLYMPUS trial who achieved a
complete response after primary chemoablation with JELMYTO (n=41,
20 of whom entered the long-term follow-up study), the median
duration of response was 47.8 months (median follow-up 28.1 months
[95% CI 13.1, 57.5]). The study results are published online in the
Journal of Urology.
“The median DOR of 47.8 months in patients who achieved complete
response with JELMYTO provides evidence of robust durability in
maintaining control of low-grade UTUC over an extended period,”
said Phillip Pierorazio, M.D., Chief, Section of Urology, Penn
Presbyterian Medical Center, Professor of Surgery, Hospital of the
University of Pennsylvania in Philadelphia, P.A., study author and
member of the American Urological Association (AUA)/ Annual Society
of Urological Oncology (SUO) UTUC Guideline Committee. “The AUA/SUO
recommend that urologists use kidney-sparing techniques as the
preferred management strategy for patients with low-grade UTUC when
possible. JELMYTO, with this evidence for extended durability of
complete response, offers the opportunity for durable
recurrence-free intervals.”
Of the 71 patients enrolled in OLYMPUS, 41 achieved a complete
response after treatment with JELMYTO and had a median duration of
response of 47.8 months (95% CI 13.0, not estimable), with median
follow-up of 28.1 months (95% CI 13.1, 57.5).
"Previous research indicates that managing relapse and
preserving organ function should be the primary treatment goal for
LG-UTUC due to the low risk of disease progression,” said Mark
Schoenberg, M.D., Chief Medical Officer of UroGen. “We are
encouraged by the study's findings providing compelling evidence
for favorable long-term durability of JELMYTO as a primary
treatment for LG-UTUC, with increasing evidence showing extended
response times in some patients."
The analysis has certain limitations, including its post-hoc
nature and the inherent selection bias of the 20 patients enrolled
in the long-term follow-up study.
To further explore the potential of JELMYTO in treating patients
with UTUC, investigators are currently enrolling participants in
the JELMYTO uTRACT Registry to gather longitudinal real-world usage
data. As of July 10, 19 sites have been activated with 191 patients
enrolled.
About JELMYTO
JELMYTO® (mitomycin) for pyelocalyceal solution is a
mitomycin-containing reverse thermal gel containing 4 mg mitomycin
per mL gel indicated for the treatment of adult patients with
low-grade-UTUC (LG-UTUC). It is approved for adult patients with
LG-UTUC. JELMYTO is a viscous liquid when cooled and becomes a
semi-solid gel at body temperature. The drug slowly dissolves over
four to six hours after instillation and is removed from the
urinary tract by normal urine flow and voiding. It is approved for
administration in a retrograde manner via ureteral catheter or
antegrade through nephrostomy tube. The delivery system allows the
initial liquid to coat and conform to the upper urinary tract
anatomy. The eventual semisolid gel allows for chemoablative
therapy to remain in the collecting system for four to six hours
without immediately being diluted or washed away by urine flow.
About Upper Tract Urothelial Cancer (UTUC)
Urothelial cancer is the ninth most common cancer globally and
the eighth most lethal neoplasm in men in the U.S. Between five
percent and ten percent of primary urothelial cancers originate in
the ureter or renal pelvis and are collectively referred to as
UTUC. In the U.S., there are approximately 6,000 - 7,000 new or
recurrent LG-UTUC patients annually. Most cases are diagnosed in
patients over 70 years old, and these older patients often face
comorbidities. There are limited treatment options for UTUC, with
the most common being endoscopic surgery or nephroureterectomy
(removal of the entire kidney and ureter). Treatment with
endoscopic surgery can lead to a high rate of recurrence and
relapse.
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and
commercializing innovative solutions that treat urothelial and
specialty cancers because patients deserve better options. UroGen
has developed RTGel® reverse-thermal hydrogel, a proprietary
sustained-release, hydrogel-based platform technology that has the
potential to improve the therapeutic profiles of existing drugs.
UroGen’s sustained release technology is designed to enable longer
exposure of the urinary tract tissue to medications, making local
therapy a potentially more effective treatment option. Our first
product to treat LG-UTUC and investigational treatment UGN-102
(mitomycin) for intravesical solution for patients with low-grade
non-muscle invasive bladder cancer are designed to ablate tumors by
non-surgical means. UroGen is headquartered in Princeton, NJ with
operations in Israel. Visit www.urogen.com to learn more or follow
us on X (Twitter), @UroGenPharma.
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: urinary
tract infection, blood in your urine, side pain, nausea, trouble
with urination, kidney problems, vomiting, tiredness, stomach
(abdomen) pain.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1800FDA1088. You may also report side effects to UroGen
Pharma at 1-855-987-6436.
Please see JELMYTO Full Prescribing Information, including
the Patient Information, for additional information.
Forward-Looking Statements
This press release contains forward-looking statements as that
term is defined in the Private Securities Litigation Reform Act of
1995, including, without limitation, statements regarding plans to
enroll participants in the JELMYTO uTRACT Patient Registry to
gather longitudinal real-world usage data; the estimated patient
population and demographics for UTUC; the potential of UroGen’s
proprietary RTGel technology to improve therapeutic profiles of
existing drugs; and UroGen’s sustained release technology making
local delivery potentially more effective as compared to other
treatment options. These statements are subject to a number of
risks, uncertainties and assumptions, including, but not limited
to: prior results may not be indicative of results that may be
observed in the future; potential safety and other complications
from JELMYTO use in diverse UTUC patient types; and UroGen’s RTGel
technology may not perform as expected and we may not successfully
develop and receive regulatory approval of any other product that
incorporates UroGen’s RTGel technology. In light of these risks and
uncertainties, and other risks and uncertainties that are described
in the Risk Factors section of UroGen’s Quarterly Report on Form
10-Q for the quarter ended September 30, 2024, filed with the SEC
on November 6, 2024 (which is available at http://www.sec.gov), the
events and circumstances discussed in such forward-looking
statements may not occur, and UroGen’s actual results could differ
materially and adversely from those anticipated or implied thereby.
Any forward-looking statements speak only as of the date of this
press release and are based on information available to UroGen as
of the date of this release.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241126501899/en/
INVESTOR CONTACT: Vincent Perrone Senior Director, Investor
Relations vincent.perrone@urogen.com 609-460-3588 ext. 1093
MEDIA CONTACT: Cindy Romano Director, Corporate Communications
cindy.romano@urogen.com 609-460-3583 ext. 1083
UroGen Pharma (NASDAQ:URGN)
Gráfico Histórico do Ativo
De Out 2024 até Nov 2024
UroGen Pharma (NASDAQ:URGN)
Gráfico Histórico do Ativo
De Nov 2023 até Nov 2024
