Photocure with FDA Priority

Oslo Cancer Cluster member Photucure recently announced that the U.S. Food and Drug Administration (FDA) has accepted a Priority Review for an expansion of Cysview.

 

The FDA has accepted a supplemental New Drug Application (NDA) for Cysview on a priority review basis. Photocure, the Oslo, Norway-based company that developed and is marketing the drug-device system, wants to expand the labeling to include use for hospital patients not staying overnight.

Basically, a Priority Review  means that the FDA will speed up their approval process and a decision is now expected in the first half of 2018.

How Cysview Detects Cancer
Cysview is a method of detecting bladder cancer using photodynamic technology and is the only FDA approved product for use with blue light cystoscopy, where a device called a cystoscope is used to detect cancer inside the bladder.

Cysview is injected into the bladder through a catheter. It accumulates differentially in malignant cells. When illuminated with blue light from the cystoscope, the cancerous lesions fluoresce red, highlighting the malignant areas.

An important Tool
— 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.

— 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, said Kjetil Hestdal, President & CEO, Photocure ASA.

 

 

 

About Photocure:

Photocure, the world leader in photodynamic technology, is a Norwegian based specialty pharmaceutical company. They develop and commercialize highly selective and effective solutions in several disease areas such as bladder cancer, HPV and precancerous lesions of the cervix and acne.

Their aim is to improve patient care and quality of life by making solutions based on Photocure Technology accessible to patients worldwide.

Photocure was founded by the Norwegian Radium Hospital in 1997. Today, the company, headquartered in Oslo, Norway, has over 60 highly skilled employees and operates in Norway, Sweden, Denmark, Finland and the United States.