Schering-Plough’s Temodar gets FDA OK

The approval was based on data that demonstrated a significant overall survival benefit in patients who were treated with Temodar(temozolomide) in combination with radiotherapy.

Concurrent with the approval for newly diagnosed glioblastoma multiforme (GBM), Temodar also received full approval for the treatment of adult patients with refractory anaplastic astrocytoma (AA), another form of brain tumor. Temodar received accelerated approval for AA in 1999 and is currently marketed for this indication in the US.

The full approval of Temodar follows a priority review of the supplemental new drug application containing the GBM data that was submitted in September 2004.

“We are very pleased with today’s FDA action and what it means for patients with GBM, the most serious and aggressive type of malignant brain tumor,” said Dr Robert Spiegel, chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute. “This approval represents a significant advance in the treatment of brain cancer, a disease for which few effective treatments exist.”

Temodar is now indicated for use in adult patients with newly diagnosed GBM concomitantly with radiotherapy, and then as maintenance treatment after the patient has completed radiotherapy. In patients with refractory AA, Temodar is indicated for use in adult patients who have experienced disease progression on a drug regimen containing nitrosurea and procarbazine.

Schering-Plough has filed an application with the European Medicines Agency (EMEA) seeking approval of a similar indication for first-line GBM.