The Norwegian company Photocure announces that the first patient has been enrolled in the Hexvix/Cysview Market Expansion Phase 3 study on bladder cancer.
The study will investigate the use of Hexvix/Cysview in the outpatient / surveillance setting and is designed to fulfill the FDA post marketing commitments. Results from the Phase 3 study are expected to be available in 2017.
The study is a prospective, multicenter Phase 3 study comparing the detection and potential positive impact on patient management of bladder cancer in the outpatient setting with Hexvix/Cysview using Blue Light enabled flexible cystoscopy versus white light flexible cystoscopy. Eighteen top rated cancer hospitals in the USA will participate in the study, which is planned to enroll approximately 360 patients with non-muscle invasive bladder cancer.
There are approximately 1.2 million flexible cystoscopy procedures conducted on a yearly basis in the United States. The use of Blue Light Flexible Cystoscopy with Hexvix/Cysview in the outpatient / surveillance setting could allow Urologists to detect recurrences at an earlier stage, which is of great clinical benefit. Furthermore, as has been demonstrated with the current use of Hexvix/Cysview during bladder cancer resection with blue light rigid cystoscopes, the addition of Hexvix/Cysview in the surveillance of bladder cancer patients may lead to better and earlier patient management decisions resulting in improved clinical outcomes and health economic savings.
“The positive benefits of Hexvix/Cysview are well documented in numerous trials for patients undergoing bladder cancer resections during cystoscopy examination in the operating room. We are looking forward to conducting the study with Blue Light Flexible Cystoscopy with Hexvix/Cysview to confirm the benefits of this technology also in the outpatient setting. Early detection of more lesions is expected to result in better treatment decisions as well as more appropriate referrals and follow-up regimens, which in turn will reduce the burden on patients and the health care system,” said Dr. Raj Pruthi, Professor and Chair, Department of Urology, University of North Carolina, Chapel Hill.
Source: Oslo Cancer Cluster