The filing is a combination drug device application with the KARL STORZ D-LIGHT C PDD Flexible Videoscope System. The sNDA also supports the approval for repeated use of BLC with Cysview and to expand the indication include detection of carcinoma in situ (CIS).
BLC with Cysview is currently indicated for use in the U.S. as an adjunct to white light for the cystoscopic detection of non-muscle invasive cancer of the bladder (NMIBC) in patients suspected or known to have lesion(s) on the basis of a prior cystoscopy. The sNDA filing contains data from a Phase 3 clinical study comparing the detection of bladder cancer recurrence in patients undergoing surveillance cystoscopy in the outpatient setting. Results from this prospective, 17 center study with 304 patients showed that in patients undergoing surveillance cystoscopy, BLC with Cysview detected bladder cancer recurrence in 20.6% of the patients that otherwise would have been missed with white light (WL) alone, which is highly significant (p<0.0001). The study also showed that 34.6% of the patients with carcinoma in situ (CIS), a very aggressive form of bladder cancer, were detected with only BLC with Cysview but missed with white light cystoscopy (p<0.0001). Data from the Phase 3 trial was presented earlier this year at the AUA annual meeting as a late breaking plenary presentation.
“Following on from the strong Phase 3 results we presented at the AUA meeting in May, we have today filed an sNDA with the FDA to seek approval for use of BLC™ with Cysview® in the US in patients undergoing surveillance cystoscopy using a flexible scope, to expand the indication to include detection of CIS and to allow for repeated use” said Kjetil Hestdal, President & CEO, Photocure ASA. “We are committed to working with the FDA to bring this important clinical tool to the US market in 2018, so that patients and physicians can benefit from potentially better and more cost-effective management of the disease.”
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 US.1,2,3 In 2016, it is 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
Hexvix® is a drug that is taken up selectively by cancer cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLC). BLC with Hexvix® improves the detection of tumors and leads to more complete resection, less residual tumors and better management decisions (US)/ reduced risk of recurrence and progression (Nordic).
Hexvix® is the tradename in Europe, Cysview® in the US and Canada. Hexvix® is marketed and sold by Photocure in the Nordic countries and in the US with the trade name Cysview®. Photocure has a strategic partnership with Ipsen for the commercialization of Hexvix® in Europe, excluding the Nordic region. 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 GmbH & Co. KG, an international leader for more than 70 years in reusable endoscope technology, encompassing all endoscopic specialties. Based in Tuttlingen, Germany, KARL STORZ GmbH & 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 ASA
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). Information about Photocure is available at www.photocure.com.
For more information, please contact:
President and CEO, Photocure ASA
Tel: + 47 91319535
Chief Financial Officer
Tel: +47 450 55 000
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.