European approval of Temodal (temozolomide) capsules for treatment of glioblastoma multiforme

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.

The study results showed that 26 percent of the patients in the Temodal group will survive two years or longer, as compared to 10 percent 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. Temodal treatment was generally well tolerated; the most commonly observed adverse events (greater than 10%) in patients receiving Temodal in combination with radiotherapy followed by Temodal monotherapy included decreased appetite, headache, constipation, nausea, vomiting, hair loss, rash, convulsions, fatigue, diarrhea, stomatitis and blurred vision. Low white blood cells and low platelets, which are known dose-limiting toxicities for most cytotoxic agents, including Temodal, were observed. When laboratory abnormalities and adverse events were combined across concomitant and monotherapy treatment phases, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic events were observed in 8 percent of the patients. Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14 percent of the patients who received Temodal.

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