Gliadel data released

The success of Guilford Pharmaceuticals's sNDA to extend the label indication for Gliadel could depend on the company's ability to persuade the Oncologic Drugs Advisory Committee (ODAC) to accept its statistical analysis of clinical trial data. The committee is slated to consider the sNDA on Tuesday, Sept. 11.

Gliadel (polifeprosan 20 with carmustine implant), a biodegradable polyanhydride wafer that is implanted in the cavity created when a brain tumor is surgically removed, was approved by FDA in September 1996 for use as an adjunct to surgery to prolong survival in patients with recurrent glioblastoma multiforme (GBM) for whom surgical resection is indicated. In its initial NDA, GLFD sought approval for use in the first surgical operation for all types of malignant glioma, but at a June 1996 meeting, ODAC recommended the narrower indication, and FDA followed its advice. ODAC's decision to recommend restricting the label was based on dissatisfaction with the power of a European Phase III trial that was terminated early because investigators could not obtain sufficient quantities of Gliadel, which was manufactured at the time by Scios Nova. ...