Photocure, a Norwegian pharmaceutical company specialising in dermatology and cancer, has received US Food and Drug Administration (FDA)'s approval for Cysview a fluorescence-based procedure for detection of papillary bladder cancer.
Photocure will now receive a 10 million milestone payment from GE Healthcare, its US licensee, and will be eligible for undisclosed royalties once the product has been launched. Cysview is already sold in 21 European countries and Korea under the brand name Hexvix by Photocure and its licensee GE Healthcare.
Bladder cancer is the fourth most common type of cancer in men and the eighth most common in women in the US. 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. It is notoriously difficult to detect. The most common, initial sign is red-colored urine, which calls for urine cytology and cystoscopy.
Cysview cystoscopy is the first approved drug-device procedure for improved detection of bladder cancer. It is designed to induce fluorescence in the malignant cells in the bladder during a cystoscopic procedure, making it easier for the urologist to detect bladder cancer. It is the first product in a new diagnostic class known as photodynamic detection (PDD) agents. Cysview must be used with a blue light cystoscopy system from Karl Storz.
"The US FDA approval of Cysview is a tribute to the patients and researchers who participated in our studies and is the culmination of nearly 10 years of research and development by our dedicated employees. It is a significant step towards realizing our mission of transforming the lives of patients with cancer." said Kjetil Hestdal, president and chief executive officer of Photocure.
He added, "The approval of Cysview is major milestone in Photocure's transformation into a sustainably profitable specialty pharmaceutical company and demonstrates our commitment to developing innovative products from our photodynamic technology platform."
"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, professor Department of Urology at the Maryland. Anderson Cancer Center in Houston, Texas, and the lead investigator of the trial.