FDA Clears Gliadel For Brain Cancer

The US Food and Drug Administration has approved Guilford Pharmaceuticals' Gliadel, a wafer impregnated with the anticancer drug carmustine, for use as an implant after surgical removal of recurrent glioblastoma multiforme. Gliadel wafers are implanted directly into the brain, delivering drug to the tumor site with less exposure to the rest of the body.

Rhone-Poulenc Rorer, which will market the product worldwide except in Scandinavia, expects to launch Gliadel in the USA in January 1997. In the meantime it is available to patients under a treatment Investigational New Drug protocol.

It is estimated that about 8,000 individuals in the USA each year are diagnosed with malignant glioma. Glioblastoma multiforme, which occurs primarily in adults, is an especially aggressive type of malignant glioma which has proved particularly resistant to treatment.