The US FDA has granted approval of a new indication for Temodar (temozolomide). The drug, used concurrently with radiotherapy and as maintenance therapy after radiotherapy, can be used for adult patients newly diagnosed with glioblastoma multiforme (GBM), the most common form of malignant brain cancer. Temodar is manufactured by the Schering-Plough Corporation., Kenilworth, N.J.

The new approval of Temodar for GBM was based on efficacy and safety data from a large randomized controlled study conducted by the European Organization for Research and Treatment of Cancer (EORTC) in patients with newly diagnosed GBP. Patients were randomized to treatment with radiation alone or to treatment with radiotherapy plus temozolomide. In the multi-centre trial of 573 patients, median survival was improved by two and a half months in the temozolomide group, a significant benefit. The median survival was 14.6 months with radiotherapy plus temozolomide and 12.1 months with radiotherapy alone.

Temodar was previously granted accelerated approval in 1999 for the treatment of adult patients with another form of brain tumour (anaplastic astrocytoma) in relapse after chemotherapy with nitrosourea and procarbazine.

Based on the clinically important outcome in the GBM study, (GBM and anaplastic astrocytoma are closely related tumours) the anaplastic astrocytoma indication is now approved under traditional procedures, and the accelerated approval requirements no longer apply, an FDA release said.

The annual incidence of GBM is four to five cases per 100,000 persons with 8,000 to 10,000 new cases diagnosed per year in North America.