An imaging drug that boosts the chances of detecting bladder cancer has won narrow approval from the FDA.
Hexvix, developed by Photocure ASA, is injected into the patient’s bladder to illuminate cancerous lesions for doctors during a cystoscopy in which the bladder is examined for signs of bladder cancer.
In a clinical trial of 814 patients, 16% had tumours detected that went unnoticed using a traditional white light diagnostic system. However, in a follow-up test nine months later, Hexvix showed no demonstrable advantages over the white light system.
A Food and Drug Administration advisory committee voted 9-8 for the introduction of Hexvix after being persuaded that over time more tumours would be identified using the new drug than the standard white light method.
The committee concluded that, despite only showing a slight improvement in detection, the benefits of Hexvix ultimately outweighed the risks.
Copyright Press Association 2009