PhotoCure ASA has announced that Hexvix has been approved for the diagnosis of bladder cancer in 26 EU/EEA countries through the European Mutual Recognition Procedure.
Hexvix is approved for the detection of bladder cancer in patients with known or suspected bladder cancer, and will be the first product on the market that improves cystoscopic diagnosis of bladder cancer. The unanimous approval of Hexvix throughout Europe reflects the need for improvement in bladder cancer diagnosis, a company release said.
Dr. Kjetil Hestdal, president and CEO of PhotoCure, comments: "Our team has once again made an outstanding effort, getting Hexvix approved only three years after the first clinical trials. Our new product has a great market potential, and PhotoCure will now focus on launch preparations in the Nordic countries and establishment of partnerships for marketing and sales in other markets."
Bladder cancer is the third most common malignant disease worldwide, with approximately four million cystoscopies performed in the USA and Europe every year. Patients have a good prognosis if diagnosed early and treated adequately. Hexvix Imaging is an innovative and effective diagnostic method that can be used for all types of bladder cancer, and will be used as a supplement to current standard methods. It is in particular effective for carcinoma in situ (CIS), a highly malignant cancer that is difficult to see with standard white light cystoscopy, the release stated.
PhotoCure has two products with sales and marketing approvals: Metvix, which is a product developed for the treatment of skin cancer (basal cell carcinoma) and pre-cancerous skin lesions (actinic keratosis), and Hexvix, which is developed for the detection of bladder cancer.