United States of America - The Food and Drug Administration (FDA) has approved porfimer sodium Injection (Photofrin®) for the ablation of precancerous lesions (high-grade dysplasia) in Barrett oesophagus patients who do not undergo surgery to remove the oesophagus (oesophagectomy).
Barrett oesophagus is a condition in which oesophagus lining is replaced by a type of tissue similar to that normally found in the intestine. Barrett oesophagus is estimated to affect about 700 000 adults in the United States. It is associated with the very common condition gastro-oesophageal reflux disease or GERD.
While Barrett oesophagus may cause no symptoms itself, a small number of people with this condition develop pre-cancerous lesions that progress to an often deadly type of cancer of the oesophagus called oesophageal adenocarcinoma.
Porfimer sodium is a photosensitizing agent used in photodynamic therapy (PDT), a treatment for some types of cancer. PDT is based on the discovery that photosensitizing agents can kill one-celled organisms when the organisms are exposed to a particular type of light. PDT destroys cancer cells through the use of a laser light in combination with a photosensitizing agent. FDA first approved porfimer sodium in 1998.
The clinical study supporting this new use of Photofrin PDT® showed that patients were more likely to achieve complete reversal of their precancerous lesions in Barrett oesophagus and had an 80% chance of being cancer-free. However, the effectiveness of Photofrin PDT® in reducing the long-term risk of oesophageal cancer has not been demonstrated.
Side effects include photosensitivity reactions and oesophageal strictures. Precautions should be taken to avoid exposure of skin and eyes to bright light.
Reference: FDA Talk paper, T03-60 4 August 2003