Home » Drug Information » FDA Approved Drugs » 1999
Medical Areas: Oncology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved August 1999
Treatment Area: Oncology
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.
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.