Photocure ASA: FDA grants priority review for Cysview® supplemental New Drug Application (sNDA)
Oslo, Norway, October 18, Photocure ASA (OSE: PHO) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Cysview® on a priority review basis. With the FDA granting a priority review, a decision is expected in the first half of 2018.
The company is looking to expand the label of Cysview to include its use in the outpatient setting to detect the recurrence of bladder cancer using a flexible cystoscope, the detection of carcinoma in situ (CIS) and the repeat administration of Cysview. The filing is a combination drug-device application, with the KARL STORZ D-LIGHT C PDD Flexible Videoscope System.
"We are delighted to see the FDA expedite the review for this sNDA as it will offer patients improved surveillance of their Non-Muscle Invasive Bladder Cancer (NMIBC)," commented Andrea Maddox-Smith CEO, Bladder Cancer Advocacy Network (BCAN). BCAN is the only national advocacy organization devoted to advancing bladder cancer research and supporting those impacted by the disease.
"We look forward to hearing a decision from the FDA early next year on the US Cysview®label expansion to include patients undergoing surveillance cystoscopy using a flexible scope. The sNDA also includes detection of CIS and to allow for repeated use in patients in the operating room and the outpatient settings", said Kjetil Hestdal, President & CEO, Photocure ASA. "Photocure is dedicated to improving the lives of patients with bladder cancer and we are committed to working with the FDA to bring this important clinical tool to the US market as soon as possible."
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®/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 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.
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
Kjetil Hestdal, President and CEO
Tel: +47 913 19 535
Erik Dahl, 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.
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