FDA accepts Gliadel Wafer sNDA for review

Guilford Pharmaceuticals' supplemental New Drug Application to the USFood and Drug Administration, which seeks approval to expand the indications for Gliadel Wafer (polifeprosan/carmustine implant) to include first-line therapy in patients newly-diagnosed with malignant glioma, has been accepted for priority review by the agency. Gliadel Wafer, which is implanted into the cavity created when a brain tumor is surgically removed to deliver chemotherapy directly to the site of the cancer while minimizing drug exposure to other areas of the body, is already approved for recurrent glioblastoma multiforme.