FDA Approves Cysview for Cystoscopic Detection of Papillary Bladder Cancer

Yael Waknine

June 04, 2010

June 4, 2010 — The US Food and Drug Administration (FDA) has approved hexaminolevulinate HCl (Cysview; GE Healthcare, under license from Photocure ASA) for the detection of non-muscle-invasive papillary bladder cancer in patients suspected or known to have lesion(s) on the basis of prior cystoscopy.

Bladder cancer, which is most likely caused by smoking, is the fourth most common type of cancer in men and eighth most common in women. The most common initial sign is red-colored urine, which calls for urine cytology and cystoscopy, usually performed under white light alone.

"Bladder cancer is an underserved disease that is both difficult to detect and has a high rate of recurrence, which places an extra burden on both patients and families. It truly is the elephant in the room," observed Diane Zipursky Quale, president and cofounder, Bladder Cancer Advocacy Network, in a company news release.

Hexaminolevulinate was developed to combat difficulties in diagnosing bladder cancer. When injected into the bladder via catheter, it accumulates differently in malignant cells, highlighting tumors as bright red spots when viewed with blue light from the cystoscope.

The optical imaging agent is used with the D-Light C Photodynamic diagnostic system (Karl Storz) to perform cystoscopy, with the blue light setting (mode 2) as an adjunct to the white light setting (mode 1).

According to a company news release, clinical trial data show that use of hexaminolevulinate and blue light cystoscopy as an adjunct to white light cystoscopy is significantly more effective than white light cystoscopy alone for detecting non-muscle-invasive papillary cancer.

"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 H. Barton Grossman, MD, professor, Department of Urology, M.D. Anderson Cancer Center, Houston, Texas, and lead investigator of the trial, in a company news release. "We found this to be true both for patients with initial and recurrent disease."

Hexaminolevulinate is not for repetitive use and is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer. It should not be used in patients with prophyria or with known hypersensitivity to hexaminolevulinate.

Rare adverse events reported with use of hexaminolevulinate include anaphylactoid shock, bladder pain, cystitis, and abnormal urinalysis. Safety and efficacy have not been established in pediatric patients and those receiving intravesical chemotherapy or Bacillus Calmette-Guérin treatment within 3 months of hexaminolevulinate photodynamic blue light cystoscopy.

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