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Guilford Gliadel Wafer

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

An sNDA for Gliadel (carmustine wafer) will be reviewed by the Oncologic Drugs Advisory Committee Sept. 11 for first-line use 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 supplemental application was submitted in April and is receiving priority review. Guilford estimates that the first-line indication would triple the potential patient population for the drug from 3,500 to 10,000-12,000. Gliadel currently is approved for recurrent glioblastoma multiforme

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