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FDA Approved Drugs » 1999
Medical Areas: Oncology

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Temodar

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Schering-Plough
Approval Status: Approved August 1999
Treatment Area: Oncology

General Information

Temodar (temozolomide) capsules have been approved for the treatment of adult patients with refractory anaplastic astrocytoma. Temodar is the first new chemotherapy agent for this type of brain tumor approved in the U.S. in 20 years.

The median survival time for patients with this disease ranges from two to three years from the time of initial diagnosis. Despite intensive treatment with surgery, radiotherapy, and chemotherapy, these patients almost invariably experience tumor recurrence, often within a year of completing first-line therapy. The annual incidence of anaplastic astrocytoma in the United States is one to 1.5 cases per 100,000 persons, with 2,000 to 3,000 new cases diagnosed per year.

Side Effects

In the clinical study, thrombocytopenia and neutropenia was the dose-limiting adverse event. The most common side effects were nausea, vomiting, headache, fatigue, and constipation.

Mechanism of Action

Temodar, an oral cytotoxic alkylating agent, is the lead agent in a new class of compounds known as imidazotetrazines. Cytotoxic agents are designed to prevent the replication of cells that divide rapidly, including those in tumors.