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ODAC limits backing for Guilford's Gliadel
Monday, June 17, 1996
GAITHERSBURG, Md. - The FDA's Oncologic Drugs Advisory Committee (ODAC) voted 7-0 with one abstention Friday to recommend approval of Guilford Pharmaceutical Inc.'s Gliadel Wafer (polifeprosan 20 with carmustine) when used in conjunction with surgery that occurs after the first surgery for malignant glioblastoma multiforme, a common form of brain cancer.
GLFD had sought approval in conjunction with both the first surgical operation for all types of malignant glioma, and subsequent operations for all types of recurring malignant gliomas. But the committee recommended limiting the indication to surgery that occurs after the first operation, and to limit treatment to the more severe malignant glioblastoma multiforme (GBM).
Investors reacted by knocking $6.875 off GLFD shares, which closed at $27.875 on 2.7 million shares traded.
Gliadel, already provided to patients under an October 1995 Treatment IND, is a biodegradable polyanhydride wafer that is implanted in the cavity created when a brain tumor is surgically removed. Seven or eight wafers are placed in the cavity, where they erode, releasing the cancer chemotherapeutic carmustine (BCNU) directly to the tumor site over a period of weeks or months.
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