Schering-Plough has announced that Schering-Plough K.K., the company's operation
in Japan, has submitted a new drug application to the Japanese Ministry of Health,
Labor and Welfare, seeking marketing approval of Temodal (temozolomide) capsules
for the treatment of malignant glioma.
Malignant gliomas are primary brain tumors that develop from glial cells. Approximately 30 percent of primary brain tumors are gliomas, which affect approximately six to eight people per 100,000 people worldwide. Both glioblastoma multiforme (GBM) and anaplastic astrocytoma are types of gliomas. GBM is the most common and aggressive form of primary brain tumor.
Temozolomide is an oral, cytotoxic alkylating agent. Cytotoxic agents are designed to prevent the replication of cells that divide rapidly, including those in tumors. In June, Temodal received marketing approval in the European Union for the treatment of patients with newly diagnosed GBM concomitantly with radiotherapy and subsequently as monotherapy treatment.