The European Commission has granted approval for Schering-Plough Corporation's Temodal (temozolomide) Capsules for first-line use for the treatment of patients with newly diagnosed glioblastoma multiforme (GBM), the most common and aggressive form of primary brain cancer.
The approval follows a positive opinion granted on April 21, 2005, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).
The approval of Temodal in combination with radiotherapy followed by up to six cycles of Temodal monotherapy is valid in the current 25 EU Member States as well as in Iceland and Norway. The approval is based largely on efficacy and safety data from the landmark Phase III study conducted by the European Organisation for Research and Treatment of Cancer (EORTC) and the National Cancer Institute of Canada (NCIC) Clinical Trial Group, release from the company said.
These data were published in the March 10, 2005, edition of the New England Journal of Medicine. In this multi-centre trial of 573 patients with newly diagnosed GBM, significant improvement in overall survival was observed in patients who were treated with Temodal in combination with radiotherapy compared with those treated with radiotherapy alone.
"Newly diagnosed GBM patients and their physicians now have an opportunity to combat this most aggressive brain tumour in its early stages. As demonstrated in our clinical trial, Temodal provides a significant improvement in survival compared to standard therapy," said Roger Stupp, University Hospital Multidisciplinary Oncology Centre in Lausanne, Switzerland and lead investigator of the EORTC/NCIC trial.
Glioblastoma multiforme (GBM) is a rapidly growing neuroglia cell tumour of the central nervous system, most often located in the cerebrum. It is the most common and deadliest type of primary brain tumour. GBM is more common among males and occurs more frequently in Caucasians. The median age at which people are diagnosed with GBM is 50 to 60 years. In Europe, an estimated 10,000 patients are diagnosed with glioblastoma multiforme each year in EU member countries.
Temozolomide is an oral, cytotoxic alkylating agent. Cytotoxic agents are designed to prevent the replication of cells that divide rapidly, including those in tumours.