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GE Healthcare Cysview Receives FDA Approval

GE Healthcare, a unit of General Electric Company, has received FDA approval for its Cysview (hexaminolevulinate HCl) for the detection of non-muscle-invasive papillary cancer of the bladder in patients with known or suspected bladder cancer.

GE Healthcare 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 lesions on the basis of a prior cystoscopy.

Cysview is used with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system to perform cystoscopy with the blue light setting (Mode 2) as an adjunct to the white light setting (Mode 1).

GE Healthcare said that the difficulties in diagnosing bladder cancer and a high rate of recurrence led to the development of Cysview cystoscopy. When injected into the bladder through a catheter, it accumulates differentially in malignant cells. When illuminated with blue light from the cystoscope, the cancerous lesions emit red fluorescence, highlighting the malignant areas.

Cysview is licensed by GE Healthcare from Photocure ASA, a Norwegian pharmaceutical company, that develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of cancer and selected dermatology indications.

Eric Cantor, head of medical affairs for GE Healthcare’s Medical Diagnostics Business in the Americas, said: “Phase III clinical data supplied with the New Drug Application (NDA) demonstrated a significantly improved rate of detection of non-muscle-invasive papillary cancer using Cysview cystoscopy compared to standard white light cystoscopy alone in patients with non-muscle-invasive papillary bladder cancer.

“The use of Cysview and blue light cystoscopy enables physicians to detect bladder tumors more accurately than with standard white light technology. The introduction of Cysview is a reflection of our commitment to providing innovative advances in diagnostic oncology.”

Barton Grossman, professor of department of Urology at the M D Anderson Cancer Center in Houston, Texas and lead investigator of the trial, said: “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. We found this to be true both for patients with initial and recurrent disease.”