The U.S. Food and Drug Administration (FDA) has informed Photocure (Oslo, Norway) that the new drug application (NDA) for Hexvix for detection of noninvasive papillary bladder cancer may be approved pending approval of the PMA (premarket approval) for the Karl Storz (Tuttlingen, Germany) photodynamic diagnosis system, and final agreements between Photocure and the FDA on labeling and postmarketing commitments. The photodynamic diagnosis system is the blue light cystoscopy system that will be used with Hexvix on the US market. Photocure expects the pending issues to be agreed with FDA within the first half year of 2010.

Hexaminolevulinate is marketed under the name Hexvix in the European Union (EU). The name to be used in the United States is currently being discussed with the FDA.

Photocure submitted the NDA on June 30, 2009, and achieved a priority review in August 2009. The NDA includes data from one pivotal and four supportive phase III studies. The pivotal phase III study in 814 patients showed a significantly improved detection (p = 0.001) of noninvasive papillary bladder cancer using Hexvix cystoscopy compared to standard white light cystoscopy in patients with suspicion of noninvasive papillary bladder cancer. The improved detection was followed by a significant reduction (p = 0.026) in recurrence at nine months. All supportive phase III studies confirmed the improved detection using Hexvix.

GE Healthcare (Chalfont St. Giles, UK) licensed the global marketing and distribution rights for Hexvix from Photocure in 2006. Photocure will, according to the license agreement with GE Healthcare, receive a milestone payment when the NDA and the PMA for the medical device is approved. The medical device is the blue light cystoscopy system from Karl Storz, GmbH. This system is currently under a PMA review by FDA.

Kjetil Hestdal, president and CEO of Photocure commented, “We are pleased that FDA acknowledge the medical need for improved detection of bladder cancer. We believe this new product will result in significant patient benefit in the diagnosis and management of bladder cancer. In Europe, Hexvix has already been used by over 57,000 patients since approval in 2005. We look forward to FDA’s approval and the subsequent launch by GE Healthcare on the US market.”

Globally, bladder cancer is ranked fourth and eighth in men and women, respectively, as the most common form of cancer causing mortality. It is expected that the incidence of bladder cancer will continue to increase concurrent with an increase in industrialization, lifestyle factors, and an aging population.

Risk factors for bladder cancer include age, tobacco use, occupation (carcinogens in the workplace), infections, drinking arsenic-contaminated water, Caucasian race, male gender, family history, treatment with chemotherapy or radiation therapy, low fluid consumption, and personal history of the disease. Common symptoms of bladder cancer include blood in the urine (making the urine slightly rusty to deep red), pain during urination, and frequent urination, or feeling the need to urinate without results.

Related Links:
Photocure
Karl Storz
GE Healthcare