Guilford's Gliadel OKed for new use in EU
Guilford Pharmaceuticals of the USA says that its proprietary treatmentfor brain cancer, Gliadel Wafer (polifeprosan 20 with carmustine implant), has been awarded extended marketing authorization in Europe to include use in newly-diagnosed patients with high-grade malignant glioma as an adjunct to surgery and radiation.
Under the European Union's Mutual Recognition Procedure, Gliadel is approved for this new use in France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain and the UK.
The product is a biodegradable wafer, implanted at the time of surgery, that delivers chemotherapy directly to the tumor site. It was previously cleared for use only in recurrent surgery for glioblastoma multiforme (Marketletters passim).
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