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CHMP Recommends Approval in the European Union (EU) for New Options for Patients With Certain Primary Brain Tumors
Date:12/8/2008

g regimen containing nitrosourea and procarbazine, and for the treatment of newly diagnosed GBM concomitantly with radiotherapy and then as maintenance treatment.

About Malignant Gliomas

The worldwide incidence rate of primary malignant brain and central nervous system tumors, using the world standard population, is 3.7 per 100,000 person in males and 2.6 per 100,000 person in females(1). The most common type of primary malignant brain tumors are gliomas, with AA and GBM being the most common and among the most serious types.

Important Information Regarding EU Labeling for TEMODAL

Full prescribing information for TEMODAL can be found at http://www.emea.europa.eu/humandocs/Humans/EPAR/temodal/temodal.htm

Important Information Regarding US Labeling for TEMODAR

TEMODAR Capsules are contraindicated in patients who have a history of hypersensitivity to any of its components, or to DTIC.

Patients treated with TEMODAR Capsules may experience myelosuppression including prolonged pancytopenia, which may result in aplastic anemia, which in some cases has resulted in a fatal outcome. In some cases, exposure to concomitant medications associated with aplastic anemia including carbamazepine, phenytoin, and sulfamethoxazole/trimethoprim complicates assessment. Geriatric patients and women have been shown in clinical trials to have a higher risk of developing myelosuppression. Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukemia, have also been observed.

TEMODAR may cause fetal harm when administered to a pregnant woman. Nursing should be discontinued in women taking TEMODAR.

Prophylaxis against Pneumocystis carinii pneumonia is required for all patients receiving
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SOURCE Schering-Plough Corporation
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