Schering-Plough announced today that the European Commission has granted approval of 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.
These data were published in the March 10, 2005, edition of the New England Journal of Medicine. In this multicenter 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 tumor in its early stages. As demonstrated in our clinical trial, Temodal provides a significant improvement in survival compared to standard therapy," said Roger Stupp, M.D., University Hospital Multidisciplinary Oncology Centre in Lausanne, Switzerland and lead investigator of the EORTC/NCIC trial.
"It is important for patients throughout the EU to have access to this important treatment advance for this devastating disease," said Robert J. Spiegel, M.D., chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute.