Temodal gains EU approval to treat aggressive 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).

Temodal (temozolomide) in combination with radiotherapy followed by up to six cycles of Temodal monotherapy is now 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.

In the multicenter trial of 573 patients with newly diagnosed glioblastoma multiforme (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.

The study results showed that 26%of the patients in the Temodal group will survive two years or longer, as compared to 10% for those who received radiotherapy alone, doubling the survival rate at two years. Median survival in the Temodal group was also significantly better (14.6 vs. 12.1 months) compared to the radiotherapy only group.

“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 Dr Roger Stupp, University Hospital Multidisciplinary Oncology Centre in Lausanne, Switzerland and lead investigator of the EORTC/NCIC trial.