In Brief: FDA Oncologic Drugs Advisory Committee
Executive Summary
FDA Oncologic Drugs Advisory Committee: Will review Pharmacia & Upjohn's Camptosar (irinotecan) injection (NDA 20-571) June 13 for metastatic carcinoma of the colon where disease has recurred or progressed following 5FU-based therapy. The committee also is slated to review Ciba-Geigy's Aredia (amidronate disodium) injection (NDA 20-036/S-011) for use in conjunction with standard antineoplastic therapy for osteolytic bone metastases. Guilford's Gliadel (carmustine) wafer (NDA 20-637), an adjunct to brain surgery to prolong survival in patients with malignant glioma, will be reviewed June 14. The meetings will begin at 8:30 a.m. each day at the Gaithersburg, Md. Holiday Inn...