FDA approves GEs imaging agent used for bladder cancer

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The FDA has approved GE Healthcare’s Cysview (hexaminolevulinate HCl) for the detection of non-muscle-invasive papillary cancer of the bladder in patients with known or suspected bladder cancer.

Cysview is an optical imaging agent indicated for use in the cystoscopic detection of non-muscle-invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy, according to the company. Cysview is used with the Karl Storz D-Light C Photodynamic Diagnostic system to perform cystoscopy with the blue light setting as an adjunct to the white light setting.

In the U.S., bladder cancer is the fourth most common type of cancer in men and the eighth most common in women, according to the National Cancer Institute. The most likely cause of bladder cancer is smoking. Difficult to detect, the most common, initial sign is red-colored urine, which calls for urine cytology and cystoscopy.

Cysview is licensed by GE from Photocure, a Norwegian company that develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of cancer and selected dermatology indications. Per the product marketing authorization for the blue light cystoscopy system from Karl Storz, hexaminolevulinate HCl is approved in Europe and marketed as Hexvix.