Schering-Plough wins European and FDA approvals for cancer drug

Schering-Plough has received both the European Commission and the FDA approvals for the intravenous formulation of temozolomide as an alternative to the already approved oral form of the drug. Temozolomide is marketed as Temodal in the EU and as Temodar in the US.

The EU Commission decision was based on the positive opinion from the European Committee for Medicinal Products for Human Use of the European Medicines Agency in November 2008. On January 22, 2009, the commission approved a sachet packaging presentation for Temodal capsules.

According to the company, this new presentation provides greater patient convenience and flexibility. On February 17, 2009, the commission approved an IV formulation of Temodal. On February 27, 2009, Schering-Plough received approval from the FDA for the Temodar IV formulation.

Temodal is a chemotherapy agent approved in the EU for treatment of patients with newly diagnosed glioblastoma multiforme (GBM) concomitantly with radiotherapy and subsequently as monotherapy, and for patients with malignant gliomas, such as GBM or anaplastic astrocytoma (AA), showing recurrence or progression after standard therapy.

In the US, Temodar is approved for the treatment of adult patients with newly diagnosed GBM concomitantly with radiotherapy and then as maintenance treatment, as well as for refractory AA.

Robert Spiegel, chief medical officer of Schering-Plough Research Institute, said: These two new options recognize Schering-Plough’s commitment to providing effective treatments in a variety of presentations for specific patient needs and patient convenience.