European Commission and United States Food and Drug Administration (FDA) Both Approve New Options for Patients With Certain Primary Brain Tumors

3 March 2009

Schering-Plough Corporation today announced that the European Commission and the US FDA both approved the intravenous (IV) formulation of temozolomide as an alternative to the already approved oral form of the drug. Temozolomide is marketed as TEMODAL(R) in the EU and as TEMODAR(R) in the US. The EU Commission Decision was based on the positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) in November 2008. On January 22, 2009, the Commission approved a sachet packaging presentation for TEMODAL Capsules. 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 US 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, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.

"TEMODAR is a well recognized, effective treatment for patients with newly diagnosed GBM. The newly approved IV formulation of TEMODAR provides patients with an important alternative method of administration, and the European TEMODAL sachet presentation offers flexibility and a convenient alternative form of packaging," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "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."

Commento Personale: E’ stato approvato l’utilizzo del Temodal anche per via endovenosa aggiungendo ulteriore flessibilità per tutti i pazienti affetti da glioblastoma multiforme. Ora non sò con che tempi, francamente, gli ospedali italiani si possano adeguare a questa novità. Sappiate, tuttavia, che i malati ora hanno il diritto di valutare anche l’utilizzo del Temodal, oltre che per via orale, per via endovenosa.

Source PrNewswire