Photocure - Urology Experts publish guidelines for best use of BLC with Cysview® in the surveillance of bladder cancer

Oslo, Norway April 25th, 2019, Photocure ASA (Photocure, PHO: OSE), today announced an Expert Consensus on the optimal use of Blue Light Cystoscopy (BLC™) with Cysview® in Nature Reviews Urology.

An expert panel published their consensus opinion regarding when and how to use Cysview, to detect bladder cancer using a flexible cystoscope. Link: Nature Reviews Consensus

The expert panel of Urologists discussed key factors that must be considered to use BLC with Cysview in everyday practice after an extensive review of literature, their key conclusions were:

A strong recommendation for:

  • the first follow-up cystoscopy at 3 months after TURBT for intermediate and high-risk patients
  • at the 3 and 6 months surveillance cystoscopy, and then every 6 months for high risk patients in the first two years

Most recommended:

  • prior to intravesical therapy if there is concern for residual disease after TURBT
  • use at time of office fulguration and/or biopsy for low grade tumors

In addition, it was concluded that BLC with Cysview may have a role in evaluating patients with a positive cytology or equivocal lesions on WLC.

“BLC with Cysview has been included in the AUA/SUO guidelines since 2016, and has strong data supporting its use to improve detection of cancer over white light cystoscopy. The 2019 Nature publication provides a road map for when to use BLC with Cysview during office cystoscopy as well as how to integrate it into clinical practice.  The University of Texas Southwestern (UTSW) was the first hospital in the United States to integrate Cysview into the clinic setting for surveillance cystoscopy as well as for TURBT in the operating room.  By using BLC with Cysview for patients in surveillance patient outcomes should improve and provide benefits to patients and those managing Non-Muscle Invasive Bladder Cancer (NMIBC),” says Dr. Yair Lotan M.D., Professor of Urology Helen J. and Robert S, Strauss Professorship in Urology, UTSW and the lead author on the Consensus paper.

“The expanded US label for BLC with Cysview being supported by practical recommendations for use means that more patients will have access to better management of their disease. This is an important step towards our vision of driving change in bladder cancer management,” commented Dan Schneider, President and Chief Executive Officer of Photocure ASA.

About Bladder Cancer
Bladder cancer is the fifth most commonly diagnosed cancer in the US and is the fourth most common cancer found in men in the US1, 2, 3. In 2018, it is estimated that there will be 81,190 new cases of bladder cancer will occur along with 17,240 deaths due to bladder cancer. Risk factors for bladder cancer include advancing age, cigarette smoking, occupational exposure to dyes, tar, rubber and solvent, chronic bladder irritation and infections, and prior diagnosis of bladder cancer. Bladder cancer is one of the most expensive cancers to manage, accounting for approximately $3.7 billion in direct costs each year4,5

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 is still in the inner layer of cells. These cancers are the most common (75%) 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 (BLC™). BLC™ 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 Cysview® /Hexvix® 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 http://bit.ly/PHOPartners for further information on our commercial partners.

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA. 

About Photocure ASA
Photocure, The Bladder Cancer Company, delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, which makes cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo Stock Exchange (OSE: PHO). The US headquarters for Photocure Inc., are in Princeton, New Jersey. For more information, please visit us at www.photocure.com, www.hexvix.com or www.cysview.com 

For further information, please contact:         

President and CEO, Daniel Schneider
Tel: +1 5084108044
E-mail: ds@photocure.com

CFO Erik Dahl
Tel: +47 450 55 000
E-mail: ed@photocure.com

1. SEER Cancer Statistics Factsheets: Bladder Cancer. National Cancer Institute. Bethesda, MD. https://seer.cancer.gov/statfacts/html/urinb.html. Accessed April 2018.

2. Bladder Cancer. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2018.

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.