Jane S. Ricciuti, RPh, MS

Disclosures

March 19, 2003

In This Article

Antineoplastic Agents

Gliadel Wafer
(polifeprosan 20 with carmustine implant)

Manufacturer: Guilford Pharmaceuticals Inc.

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 02/25/03)

New Indication: Gliadel Wafer is now indicated in newly diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation therapy.

Dosing: A single Gliadel Wafer contains 7.7 mg of carmustine, resulting in a dose of 61.6 mg when 8 wafers are implanted.

Clinical Summary: In a single, randomized, double-blind, placebo-controlled clinical trial in 240 adult patients with newly diagnosed high-grade malignant glioma undergoing initial craniotomy for tumor resection, treatment with Gliadel Wafer implants plus surgery and radiation was compared to placebo implants plus surgery and radiation therapy. The most common tumor type was glioblastoma multiforme (n = 207).

Patients were followed for at least 3 years or until death. Median survival increased from 11.6 months with placebo to 13.9 months with Gliadel Wafer.

Gliadel Wafer (polifeprosan 20 with carmustine implant) Labeling

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