Cysview(TM) (Hexaminolevulinate HCL) Approved by the FDA for Cystoscopic Detection of Papillary Bladder Cancer

PRINCETON, N.J., May 28 /PRNewswire/ -- GE Healthcare, a unit of General Electric Company (NYSE: GE), today announced that the US Food and Drug Administration (FDA) has approved 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. 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) .

"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," said Eric Cantor, MD, Head of Medical Affairs for GE Healthcare's Medical Diagnostics Business in the Americas. "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."

More than 70,000 people in the US were diagnosed with cancer of the bladder in 2009, with an estimated 14,000 people dying from the disease, according to the National Cancer Institute. Bladder cancer is the fourth most common type of cancer in men and the eighth most common in women. 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.

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

The standard bladder cancer diagnostic procedure combines urinary cytology and white light Cystoscopy. Cytology is non-invasive, using a urine sample to detect cancer cells. This provides specificity and sensitivity in detecting high-grade lesions, but provides no information on the location and extent of the disease. If the test is positive for cancer cells, the next step is direct visual inspection of the urothelium and mucosa with white light cystoscopy to localize the tumors. In addition, during this procedure the physician can perform a transurethral resection of suspicious areas of the bladder. Finally, the samples can be tested to determine if they are malignant.

"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," said Diane Zipursky Quale, President and Co-Founder, Bladder Cancer Advocacy Network (BCAN). "The availability of an innovative technology that provides the opportunity for an early diagnosis allows patients to seek appropriate attention faster, treat the disease, and have a better chance of survival."

The difficulties in diagnosing bladder cancer and a high rate of recurrence led to the development of Cysview cystoscopy. Cysview, an optical imaging agent, is injected into the bladder through a catheter. Cysview 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 (OSE:PHO), a Norwegian pharmaceutical 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 (PMA) for the blue light cystoscopy system from Karl Storz, hexaminolevulinate HCl is approved in Europe and marketed as Hexvix.

Prior to Cysview administration, please read the full prescribing information and follow the preparation and reconstitution instructions.

For information about Cysview, please call (800) 658-0118, select option two, and then option three.

Important Risk and Safety Information about Cysview

Product Indication:

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. 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).

Cysview is not for repetitive use and is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer.

Product Risk Information:

Safety and effectiveness have not been established in patients receiving intravesical chemotherapy or BCG treatment within 3 months of Cysview photodynamic blue light cystoscopy, nor in pediatric patients.

Cysview should not be used in patients with porphyria or with known hypersensitivity to hexaminolevulinate HCl. There are no known drug interactions with hexaminolevulinate HCl; however, no specific drug interaction studies have been performed.

Cysview must be used with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system. For system set up and general information for the safe use of the PDD system, please refer to the Karl Storz instruction manuals for each of the components.

For additional information on adverse reactions see the end of this release.

The following adverse reactions have been identified during post-approval use of Cysview. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cases of anaphylactoid shock, bladder pain, cystitis and abnormal urinalysis have uncommonly been reported.

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SOURCE GE Healthcare