Schering-Plough Corporation has reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending approval of Temodal (temozolomide) Capsules for first-line use in the treatment of patients with newly diagnosed glioblastoma multiforme (GBM), the most common form of brain cancer. The CHMP recommendation serves as the basis for a European Commission approval.

Temodal is currently approved in the European Union (EU) for the treatment of patients with malignant glioma such as GBM or anaplastic astrocytoma, showing recurrence or progression after standard therapy. Schering-Plough received full approval of temozolomide (Temodar) from the US Food and Drug Administration (FDA) on March 16, 2005 for the treatment of adult patients with newly diagnosed GBM when administered in combination with radiotherapy and then as maintenance therapy.

A Commission approval would result in centralised Marketing Authorization with unified labelling throughout the EU, covering the use of Temodal for the treatment of patients with newly diagnosed GBM concomitantly with radiotherapy followed by up to 6 cycles of temozolomide monotherapy. The new labelling 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 release said.

The positive opinion recommending the labelling 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).

Temozolomide is an oral, cytotoxic alkylating agent. Cytotoxic agents are designed to prevent the replication of cells that divide rapidly, including those in tumours.