OSLO, Norway, Feb. 16, 2018 /PRNewswire/ -- Photocure
ASA (OSE: PHO), announced today that the U.S. Food and Drug
Administration (FDA) approved its supplemental new drug application
(sNDA) to extend the indication for Blue Light Cystoscopy (BLC™)
with Cysview® to include Flexible
Cystoscopes, which are used in the ongoing surveillance of patients
with bladder cancer. This is the only combination of drug and
device approved for the detection of bladder cancer.
The approval of this new indication is based on the results from
a large Phase 3 study using KARL
STORZ blue light enabled rigid and flexible cystoscopes.
This study showed that BLC™ significantly (p<0.0001) improves
detection of patients with recurrent bladder cancer. Click here for
the new PI.
"This approval is an important milestone for Photocure.
With 1.2 million surveillance cystoscopies performed annually in
the U.S., this represents a significant opportunity for the company
and allows us to bring solutions to current clinical challenges,"
said Kjetil Hestdal M.D. Ph.D., President & CEO. "The expanded
label now allows repetitive use in the same patient which enables
physicians to provide an improved continuum of care to their
bladder cancer patients and should lead to reduced cost."
The expanded indication includes the combination of Cysview with
the KARL STORZ PDD Flexible Blue Light Videoscope System. The
approval also expands the indication in the current rigid setting
(TURBT) by including the detection of carcinoma in situ (CIS) in
bladder cancer patients as well as the repeated use of BLC with
Cysview.
"This expanded approval in both rigid and flexible blue light
cystoscopy (BLC) means that Cysview can now be used during
transurethral resection of bladder cancer surgery for diagnosis and
staging, as well as with follow-up surveillance of non-muscle
invasive bladder cancer (NMIBC). Patients with NMIBC, especially
NMIBC, require careful and frequent follow-up due to the high rate
of recurrence and progression. Blue light cystoscopy with Cysview,
will enable physicians to provide appropriate and more accurate
treatment earlier, which in my experience results in improved
outcomes for my patients. In my high-risk NMIBC clinical
practice, I recognize the benefit of using BLC with Cysview to more
readily detect carcinoma in-situ, i.e. aggressive high-grade flat
lesions. In this study, an additional 35% of CIS patients were
found by using BLC with Cysview alone and missed with white light,"
says Gary Steinberg, M.D., The Bruce
and Beth White Family Professor, Vice Chairman and Director of
Urologic Oncology, University of
Chicago Medicine.
In collaboration with KARL STORZ Endoscopy-America, Inc.,
Photocure plans to launch Cysview in combination with blue light
enabled flexible video cystoscopy in mid-2018.
For more information about the study:
https://clinicaltrials.gov/ct2/show/NCT02560584
About Bladder Cancer
Bladder cancer is the fifth most commonly diagnosed cancer in
the U.S. and is the fourth most common cancer found in men in the
U.S.1,2,3 In 2016, it was estimated that 76,960 new
cases of bladder cancer will occur along with 16,390 deaths due to
bladder cancer.
Bladder cancer is one of the most expensive cancers to manage,
accounting for approximately $3.7
billion in direct costs each year.4,5
Bladder cancer is classified into two types, non-muscle invasive
bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC),
depending on the depth of invasion in the bladder wall.
2 NMIBC remains in the inner layer of cells lining
the bladder. These cancers are the most common (70%) of all BC
cases and include the subtypes Ta, carcinoma in situ (CIS) and T1
lesions. MIBC is when the cancer has grown into deeper layers of
the bladder wall. These cancers, including subtypes T2, T3 and T4,
are more likely to spread and are harder to treat. 2
About
Hexvix®/Cysview®
Hexvix®/Cysview® is a drug that is
selectively taken up by cancer cells in the bladder making them
glow bright pink during Blue Light Cystoscopy
(BLCTM). BLCTM with Hexvix®
/Cysview® improves the detection of tumors and leads to
more complete resection, less residual tumors and better management
decisions.
Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in
all other markets. Photocure is commercializing
Hexvix®/Cysview® directly in the US and the
Nordic region, and has strategic partnerships for the
commercialization of Hexvix®/Cysview® in
Europe, Canada, Australia and New
Zealand. Please refer to
https://www.photocure.com/Partnering-with-Photocure/Our-partners
for further information on our commercial partners.
About KARL STORZ Endoscopy-America, Inc.
KARL STORZ Endoscopy-America, Inc., is an affiliate of KARL STORZ SE & Co. KG, an international
leader for more than 70 years in reusable endoscope technology,
encompassing all endoscopic specialties. Based in Tuttlingen,
Germany, KARL STORZ SE & Co. KG is a family-owned
company that designs, engineers, manufactures, and markets all its
products with an emphasis on visionary design, precision
craftsmanship and clinical effectiveness. For more information,
call (800) 421-0837 or visit the company's website at
www.karlstorz.com.
About Photocure
Photocure, headquartered in
Oslo Norway, is a specialty
pharmaceutical company focusing on urology. Based on its unique
proprietary Photocure Technology® platform, Photocure is
committed to developing and commercializing highly selective and
minimally invasive solutions to improve health outcomes for
patients worldwide. The company is listed on the Oslo Stock
Exchange (OSE: PHO). More information about Photocure is available
at www.photocure.com, www.hexvix.com, www.cysview.com
Company contacts:
Kjetil Hestdal, President and CEO
Tel: +47 913 19 535
Email: kh@photcure.no
Erik Dahl, Chief Financial
Officer
Tel: +47 450 55 000
Email: ed@photocure.no
References:
1. SEER Cancer Statistics Factsheets: Bladder Cancer.
National Cancer Institute. Bethesda,
MD. http://seer.cancer.gov/statfacts/html/urinb.html.
Accessed April 2016.
2. Bladder Cancer. American Cancer
Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf.
Accessed April 2016.
3. Hall M, Chang S, Dalbagni G et al. Guideline for the Management
of Nonmuscle Invasive Bladder Cancer (Stages Ta, T1, and Tis): 2007
Update. J Urol. 2007;178(6):2314-2330.
4. Avritscher EB et al., Clinical model of lifetime cost of
treating bladder cancer and associated complications. Urology.
2006; 68:549-553.
5. Botteman et al. Clinical model of lifetime costs of
treating bladder cancer: a comprehensive review of the published
literature. Pharmacoeconomics. 2003; 21:315-1330.
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and are registered trademarks of Photocure ASA
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