FDA approves optical imaging agent for bladder cancer detection

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

The optical imaging agent is used with the Karl Storz (Tuttlingen, Germany) D-Light C Photodynamic Diagnostic system to perform cystoscopy with the blue light setting as an adjunct to the white light setting.

"Data from the pivotal 305 trial demonstrates that Cysview cystoscopy significantly improves detection of papillary bladder cancer, leading to more complete resection of bladder cancer and significantly improving disease-free survival when compared to white light cystoscopy," said lead investigator H. Barton Grossman, MD, of M.D. Anderson Cancer Center, Houston. "We found this to be true both for patients with initial and recurrent disease."