Schering-Plough Corporation has been granted six-month priority review status to its supplemental New Drug Application (sNDA) for Temodar (temozolomide) Capsules for the treatment of gliomas, a form of brain tumour by US FDA. The application was submitted to FDA in September 2004.

Priority review status is granted to drugs that, if approved, would address unmet medical needs and represent significant advances over existing treatments.

The supplement provides clinical support for the potential use of Temodar in this first-line indication based on efficacy and safety data from a recently completed phase III study conducted by the EORTC in patients with newly diagnosed glioblastoma multiforme (GBM), a form of malignant glioma. Based on this data and supported by earlier clinical studies, the sNDA also seeks to broaden the current indication for Temodar to include the treatment of patients with recurrent and refractory high-grade gliomas.

Schering-Plough also noted that FDA has granted orphan-drug designation to Temodar (temozolomide) for the treatment of newly diagnosed high grade gliomas. Temodar is currently indicated and marketed in the United States for the treatment of adult patients with refractory anaplastic astrocytoma, a form of brain tumour.

Schering-Plough is seeking marketing approval for the use of Temodar for the treatment of patients with newly diagnosed high-grade gliomas concomitantly with radiotherapy and then as adjuvant treatment after the patient has completed radiotherapy.

Schering-Plough has filed a similar supplemental new drug application with the European Medicines Agency (EMEA). In the European Union, temozolomide is marketed as Temodal and is currently indicated for the treatment of patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

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