Photocure: FDA approval for new indications
Our portfolio company Photocure ASA with great news form the U.S: FDA has today approved the indication for Blue Light Cystoscopy (BLC™) with Cysview® to include Flexible Cystoscopes. This means that Photocure´s drug and device for detection of bladder cancer may also be used in the ongoing surveillance of afflicted patients.
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 improves detection of patients with recurrent bladder cancer.
“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.”
Bladder cancer is the fifth most commonly diagnosed cancer in the U.S., and also one of the most expensive cancers to manage, accounting for approximately $3.7 billion in direct costs each year.
35 % more patients diagnosed
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.
“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 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 on this news – please read the full press release from Photocure.
Facts:
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
