Temozolomide (brand name Temodar®) is an oral alkylating agent used for the treatment of refractory anaplastic astrocytoma -- a type of cancerous brain tumour. A derivative of imidazotetrazine, temozolomide is the prodrug of MTIC (3-methyl-(triazen-1-yl)imidazole-4-carboxamide). Temodar is marketed by Schering Corporation, which also markets other well-known prescription drugs such as Clarinex, Nasonex, Levitra, Cipro, Vytorin, Diprolene, Elocon and Lotrisone.

Indications

Glioblastoma multiforme: for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as manitenance treatment.
Anaplastic astrocytoma: for the treatment of adult patients with refractory anaplastic atrocytoma (ie. patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine).
Unlabeled uses: Metastatic melanoma.

Dosage Forms

Temozolomide is available in the United States in 5mg, 20mg, 100mg, & 250mg capsules.

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New Drug to Treat Recurring Brain Cancer - Brief Article
From FDA Consumer, 11/1/99

Some adult brain cancer patients now have another option for treating their disease.

The oral treatment temozolomide (Temodar) was approved by FDA in August to treat a form of brain cancer called anaplastic astrocytoma in patients who relapsed following initial treatment with radiation and chemotherapy.

Temozolomide was granted accelerated approval, a process FDA applies to some drugs for serious or life-threatening conditions. In a single study of the drug, tumors resistant to previous chemotherapy with two other drugs partially shrank and disappeared in 7 out of 54 patients. The most common side effects of temozolomide included headaches, nausea, vomiting, fatigue, and low blood counts.

At least 18,000 new cases of brain cancer are diagnosed each year in the United States, a figure which represents about 2 percent of all adult cancers. More than 50 percent of brain cancer cases are tumors that can cause severe disabilities such as motor dysfunction, seizures, and vision abnormalities.

As a condition of approval, FDA is requiring the manufacturer, ScheringPlough Corp., Madison, N.J., to further study the drug's effects on patients' survival or quality of life.

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