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| |  EU Approves Temodal For Recurrent Glioblastoma Multiforme MADISON, NJ -- Jan. 28, 1999 – The European Union’s commission of the European communities has granted marketing authorisation to Schering-Plough Corp.’s Temodal(R) (temozolomide) Capsules for the treatment of patients with glioblastoma multiforme showing progression or recurrence after standard therapy. Commission approval of the centralised application for Temodal results in a single marketing authorisation with unified labelling that is immediately valid in all 15 European Union-Member States. Schering-Plough expects to submit Type II variations seeking approval of Temodal for the treatment of patients with anaplastic astrocytoma, another type of brain cancer and malignant melanoma, the most serious form of skin cancer. Temodal, an oral cytotoxic, alkylating agent, is the lead compound in a new class of compounds known as imidazotetrazines. Glioblastoma multiforme is a rapidly growing cancer of the central nervous system, most often located in the cerebrum. It is the most common and deadliest type of malignant glioma (brain tumour), with median patient survival times ranging from nine to 12 months from initial diagnosis. Despite intensive treatment with surgery, radiotherapy and chemotherapy, patients with malignant glioma almost invariably experience tumour recurrence. Median survival in patients with recurrent high-grade glioma ranges from only three to six months from the time of recurrence.
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