On February 25, 2003, the FDA approved polifeprosan 20 with carmustine implant (GLIADEL® Wafer, a trademark of Guilford Pharmaceuticals, Inc.) as an adjunct to surgery and radiation for the treatment of patients with newly diagnosed, high-grade malignant glioma. The implantable wafer delivers the chemotherapy drug carmustine directly into the tumor site after the tumor has been removed by surgery.

In 1996, the FDA approved GLIADEL Wafer as an adjunct to surgery for the treatment of patients with recurrent glioblastoma multiforme (GBM) brain tumors.

The effectiveness of GLIADEL Wafer for the treatment of patients with newly diagnosed, high-grade malignant glioma was assessed in an international, multicenter, double-blinded, randomized, placebo-controlled Phase III trial. Two hundred and forty patients were randomized to the GLIADEL treatment arm or the placebo treatment arm. The trial design stipulated that patients would undergo initial surgery with wafer implantation followed by standard radiation therapy.

After maximal resection of the tumor, up to eight wafers containing either GLIADEL or placebo were placed against the resection cavity (the site where the tumor had been removed). Within three weeks of surgery, the majority of patients started radiation therapy.

The primary efficacy endpoint for this study was overall survival. Median survival increased from 11.6 months with placebo to 13.9 months with GLIADEL Wafer (p-value <0.05, log-rank test). The hazard ratio for GLIADEL Wafer treatment was 0.73 (95 percent CI: 0.56-0.95).

The toxicities seen in the study may reflect either the surgical procedure or implantation of the GLIADEL wafers or both. The primary toxicities were seizures, brain hemorrhages, brain cyst, and wound infection/brain abscesses.

Full prescribing information is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications.

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