The FDA has accepted a supplemental New Drug Application (NDA) for Cysview (hexaminoluvinate HCl) 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 indication to include use of the product in the outpatient setting.
In July 2010, FDA approved Cysview for use in the cystoscopic detection of non-muscle-invasive papillary bladder cancer in patients suspected or known to have lesions on the basis of prior cystoscopy.
A decision on the NDA is expected in the first half of 2018, according to Photocure.
Hexaminolevulinate HCl is an optical imaging agent indicated for use in the cystoscopic detection of non-muscle-invasive papillary bladder cancer in patients suspected or known to have lesions on the basis of prior cystoscopy. Cysview is used with the Karl Storz D-Light C Photodynamic Diagnostic System to perform cystoscopy with the blue light setting (mode 2) as an adjunct to the white light setting (mode 1).
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.
Photocure ASA: FDA grants priority review for Cysview® supplemental New Drug Application (sNDA) [news release]. PhotoCure ASA; October18, 2017.