Gastrointestinal
Drugs Advisory Committee
Food and Drug Administration
Center for Drug Evaluation and Research
“Photodynamic
therapy with Photofrinâ is indicated for the ablation of high-grade dysplasia in
Barrett’s esophagus among patients who refuse esophagectomy and who are in
overall good health.”
Meeting
Statement: Thomas H.
Perez, M.P.H., Executive Secretary
Division of Gastrointestinal and Coagulation
Drug Products
Introduction
François Martin, M.D., Senior Vice President, Scientific Affairs, Axcan Scandipharm, Inc.
Management of High-Grade
Dysplasia in Barrett’s Esophagus
Kenneth K. Wang, M.D., Associate Professor of Medicine, Mayo Clinic
Efficacy & Safety of
Photofrin Photodynamic Therapy
in
the ablation of High-Grade Dysplasia in Barrett’s Esophagus
Bergein F. Overholt, M.D., Medical Director,
Histopathology of High-Grade
Dysplasia in Barrett’s Esophagus
Mary P. Bronner, M.D., Director, GI and
Hepatic Pathology Program, The
Conclusion
François Martin, M.D., Senior Vice
President, Scientific Affairs
Medical Officer’s Presentation
Edvardas Kaminskas, M.D., Division of Gastrointestinal and Coagulation
Drug Products
Robert Justice, M.D., Director, Division of Gastrointestinal and Coagulation Drug Products