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CHMP Recommends Approval in the European Union (EU) for New Options for Patients With Certain Primary Brain Tumors
Date:12/8/2008

ormulation of TEMODAL can provide patients in the EU with an important alternative route of administration, and the sachet presentation can offer flexibility and a more convenient form of packaging," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "These two new options demonstrate Schering-Plough's commitment to providing effective treatments in a variety of presentations for specific patient needs and for patient convenience."

About temozolomide

TEMODAL (temozolomide), a cytotoxic agent, is currently approved in oral form as 5mg, 20mg, 100mg, 140mg, 180mg and 250mg capsules in Europe. Cytotoxic agents are designed to impact the replication of cells that divide rapidly, such as those in tumors. TEMODAL was initially approved in the European Union (EU) in 1999 for the treatment of patients with malignant glioma, such as GBM or AA, showing recurrence or progression after standard therapy. In June 2005, TEMODAL received marketing approval in the EU for the treatment of patients with newly diagnosed GBM concomitantly with radiotherapy and subsequently as monotherapy treatment. The TEMODAL IV formulation reviewed by the CHMP was developed for cancer patients who are unable to take TEMODAL Capsules and has shown bioequivalence to the oral product. The sachet packaging presentation for TEMODAL Capsules was created to provide greater patient convenience and flexibility.

Schering-Plough has received a Complete Response Letter from the U.S. Food and Drug Administration for the TEMODAR IV formulation and is working with the agency to address outstanding questions.

TEMODAR capsules (temozolomide) received accelerated approval from the U.S. Food and Drug Administration (FDA) for adult patients with refractory AA in 1999 and full approval in March 2005 for refractory AA, ie, patients who have experienced disease progression on a dru
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SOURCE Schering-Plough Corporation
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