Imaging Agent for Bladder Cancer Okayed

The FDA has approved Cysview (hexaminolevulinate HCl), 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.

GE Healthcare, a unit of General Electric Company, has licensed Cysview from Photocure ASA, a Norwegian pharmaceutical company.