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Guilford Gliadel in initial surgery

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Guilford's Gliadel (polifeprosan 20 with carmustine implant) gains approval Feb. 25 for newly diagnosed, high-grade malignant glioma patients as an adjunct to surgery and radiation. Approval is based on a double-blind, placebo-controlled trial in 240 patients with a follow-up period of up to 48 months. Nine of the 11 surviving patients at the last follow-up received Gliadel. Median survival with Gliadel increased to 13.9 months from 11.6 months (p<0.05); the firm says marketing for the indication will highlight survival benefit. Guilford previously estimated market penetration of 33% in the recurrent setting, but only 8% in the initial surgery market. The firm aims to increase market share in the initial surgery group to the low teens in 200
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