The treatment will be indicated for adult patients with newly diagnosed glioblastoma multiforme (GBM), a form of malignant brain cancer. Temodal (temozolomide) is currently marketed in Canada for the treatment of recurrent or progressive GBM or anaplastic astrocytoma (AA), another form of brain tumor, but not for newly diagnosed patients.
“In a disease for which few effective treatments exist, Temodal is an important component for the treatment of GBM, the most serious and aggressive type of malignant brain tumor,” said Dr Warren Mason, associate professor at the University of Toronto. “This approval provides newly diagnosed GBM patients and their families additional hope in the battle against this devastating disease.”
The new indication of Temodal follows a priority review of the supplemental new drug submission containing the GBM data that was submitted in June 2005. The approval of Temodal for newly diagnosed GBM was based on efficacy and safety data from a phase III study in patients with newly diagnosed GBM.
In this multicenter trial of 573 patients, significant improvements in overall survival were observed in patients who were treated with Temodal in combination with radiotherapy.