Gastrointestinal Drugs Advisory Committee
June 26, 2003
1. Appropriate patients for PHOTOFRIN PDT
a) The diagnosis of high-grade dysplasia was confirmed by the Central Reference Laboratory in about 50% of patients with that diagnosis. Discuss what impact the inability to confirm a high-grade dysplasia diagnosis has on the use of PHOTOFRIN. Provide recommendations to ensure use of this therapy in the appropriate population.
b) Should the diagnosis of high-grade dysplasia be confirmed by a reference laboratory of acknowledged experts before PHOTOFRIN PDT is undertaken?
a) Do the applicant’s data demonstrate efficacy of PHOTOFRIN PDT in complete ablation of high-grade dysplasia in Barrett’s esophagus?
b) Is a 2-year follow-up period adequate to demonstrate cancer risk reduction in high-grade dysplasia patients treated with PHOTOFRIN PDT?
c) How frequently should patients who have undergone PHOTOFRIN PDT be monitored by esophagoscopy?
Is the safety profile of PHOTOFRIN PDT acceptable?
The applicant is continuing to collect patient follow-up data in the PHO BAR 02 study for an additional 3 years. PHO BAR 01 and PHO BAR 02 taken together will provide a maximum of 5 years of follow-up for patients in the 2 arms of the study. Is this adequate to demonstrate cancer risk reduction in high-grade dysplasia patients?