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Application Filed for Temozolomide in European Union

BRUSSELS, Belgium, November 3/PRNewswire/ -- Schering-Plough Europe today reported that it has filed an application with the European Medicines Agency (EMEA) seeking centralized Marketing Authorization in the European Union (EU) for the use of TEMODAL(R) (temozolomide) Capsules for the treatment of patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment. Glioblastoma multiforme is a form of brain tumor.

The application provides clinical support for the potential use of TEMODAL in this first-line indication based on efficacy and safety data from a recently completed Phase III study conducted by the EORTC(1) in patients with newly diagnosed glioblastoma multiforme.

TEMODAL is currently approved and marketed in the European Union (EU) for the treatment of patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

Schering-Plough also reported that the U.S. Food and Drug Administration (FDA) has granted six-month priority review status to a similar application filed in the United States.

Temozolomide is an oral cytotoxic alkylating agent. Cytotoxic agents are designed to prevent the replication of cells that divide rapidly, including those in tumors.

The development of temozolomide for expanded indications is consistent with Schering-Plough's strategy to broaden its oncology portfolio and is in line with its plans to build strength in its global franchises through both internal research and external collaborations and licensing opportunities.

(1) Concomitant and adjuvant temozolomide (TMZ) and radiotherapy (RT) for newly diagnosed glioblastoma multiforme (GBM). Conclusive results of a randomized phase III trial by the EORTC Brain & RT Groups and NCIC Clinical Trials Group. R. Stupp, NCIC1, M. Weller, M van den Bent, NCIC2, M. Taphoorn, NCIC3, EORTC Vienna/Regensburg or Padova, D. Lacombs, R.O. Mirimanoff for the European Organization for Research and Treatment of Cancer Brain Tumor & Radiotherapy Groups and National Cancer Institute Canada; Lausanne, Switzerland; Tubingen, Germany, Toronto, ON, Canada; Rotterdam, The Netherlands; Brussels Belgium; London, ON, Canada.

Source: Schering-Plough Corporation

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