Norwegian urology-focused developer Photocure ASA said last week it won a supplemental new drug application from the FDA extending the indication for its Blue Light Cytoscopy (BLC) with Cysview to include flexible cytoscopes designed for the surveillance of patients with bladder cancer.
The company touted the approval, saying it is the only combination of drugs and devices approved for detecting bladder cancer.
Approval came based on results from a Phase 3 study that used Karl Storz blue light enabled rigid and flexible cytoscopes. Results from the study indicated that the BLC significantly improved detection of patients with recurrent bladder cancer.
“This expanded approval in both rigid and flexible blue light cystoscopy 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,” Dr. Gary Steinberg of University of Chicago Medicine said in a prepared statement.
The newly expanded indication includes the combined Cysview and Karl Storz PDD flexible blue light videoscope system, and expands the previous indication in current rigid setting to include detection of carcinoma in situ in bladder cancer patients. The expansion also includes the repeated use of BLC with the Cysview system.
“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. 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,” prez & CEO Dr. Kjetil Hestdal said in a press release.