The U.S. Food and Drug Administration (FDA) has approved the company’s 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.
“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.