Guilford Gliadel
Executive Summary
On the afternoon of Sept. 11, FDA's oncology advisory committee will review sNDA for Gliadel (carmustine wafer) for a first-line indication - to significantly prolong survival and maintain overall function as measured by preservation of Karnofsky performance status and neurologic function in patients with malignant glioma undergoing primary or recurrent surgical resection. The sNDA was submitted in April and is under priority review