Euro Committee recommends approval of Schering-Plough’s Temodal

Temodal (temozolomide) is currently approved in the EU for the treatment of patients with malignant glioma such as glioblastoma multiforme (GBM), or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

The Committee for Medicinal Products for Human Use (CHMP) recommendation serves as the basis for a European Commission approval. A Commission approval would result in centralized marketing authorization with unified labeling throughout the EU, covering the use of Temodal for the treatment of patients with newly diagnosed GBM concomitantly with radiotherapy followed by up to six cycles of temozolomide monotherapy.

The new labeling will be in addition to the currently approved indication, and will be valid in the current 25 EU Member States as well as in Iceland and Norway, once approval is granted by the European Commission.

The positive opinion recommending the labeling expansion for Temodal is based largely on efficacy and safety data from a landmark phase III study conducted by the European Organisation for Research and Treatment of Cancer (EORTC) and the National Cancer Institute of Canada (NCIC). In this trial, 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.