Schering-Plough's Temodal approved in Canada for newly diagnosed brain cancer

By Angela McDaniels

Seattle, Feb. 2 - Schering-Plough Corp. said Health Canada has granted approval for Temodal (temozolomide) capsules in combination with radiotherapy for the treatment of adult patients with newly diagnosed glioblastoma multiforme, a form of malignant brain cancer.

Temodal is marketed in Canada for the treatment of recurrent or progressive glioblastoma multiforme or anaplastic astrocytoma, another form of brain tumor.

"In a disease for which few effective treatments exist, Temodal is an important component for the treatment of glioblastoma multiforme, the most serious and aggressive type of malignant brain tumor," Warren P. Mason of the University of Toronto said in a company news release.

The new indication of Temodal follows a priority review of the supplemental New Drug Application the company submitted in June 2005.

The application included efficacy and safety data from a phase 1/2 study conducted by the National Cancer Institute of Canada and European Organisation for Research and Treatment of Cancer in 573 patients with newly diagnosed glioblastoma multiforme. Significant improvements in overall survival were observed in patients who were treated with Temodal in combination with radiotherapy, the company said.

The data was published in the March 10, 2005 edition of the New England Journal of Medicine.

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 drug is marketed as Temodar capsules in the United States.

Schering-Plough is a health care company based in Kenilworth, N.J., that develops prescription, consumer and animal health products.

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