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The Food and Drug Administration (FDA) today announced the approval of Photofrin (porfimer sodium) Injection for the ablation of precancerous lesions (high-grade dysplasia) in Barrett’s esophagus patients who do not undergo surgery to remove the esophagus (esophagectomy).
Barrett's esophagus is a condition in which the esophagus, the muscular tube that carries food and saliva from the mouth to the stomach, changes so that some of its lining is replaced by a type of tissue similar to that normally found in the intestine. Barrett's esophagus is estimated to affect about 700,000 adults in the United States. It is associated with the very common condition gastroesophageal reflux disease or GERD.
While Barrett's esophagus 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 esophagus called esophageal adenocarcinoma.
Photofrin 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 Photofrin in 1998.
The clinical study supporting this new use of Photofrin PDT showed that patients receiving Photofrin PDT were more likely to achieve complete reversal of their pre-cancerous lesions in Barrett’s esophagus compared to those who did not receive Photofrin PDT. Two-year follow-up data from this clinical study showed that patients receiving Photofrin PDT had an 80% chance of being cancer-free. Patients who did not receive Photofrin PDT had a 50% chance of being cancer-free. The effectiveness of Photofrin PDT in reducing the long-term risk of esophageal cancer has not been demonstrated.
Side effects of Photofrin PDT treatment include photosensitivity reactions and esophageal strictures. The drug’s labeling includes information on precautions that should be taken to avoid exposure of skin and eyes to bright light.
Today’s approval follows the recommendations of the June 26, 2003 meeting of the FDA’s Gastrointestinal and Coagulation Drugs Advisory Committee.
Axcan Scandipharm Inc., of Birmingham, Ala., is the sponsor of the New Drug Application (NDA) for Photofrin.
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