Temozolomide (Temodar) has been granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with refractory anaplastic astrocytoma (a form of brain cancer) who have relapsed following chemotherapy that includes a nitrosourea drug and procarbazine. It is the first new chemotherapy agent for this type of brain tumor to be approved in the United States in 20 years. Accelerated approval is a regulatory mechanism that allows early approval for a product intended to treat serious or life-threatening conditions for which no acceptable alternative treatments exist or that provides a meaningful therapeutic benefit over existing treatments.
In a single-arm, multi-center study, 162 patients who had anaplastic astrocytoma received temozolomide at first relapse. Fifty-four patients had disease progression on prior therapy with a nitrosourea and procarbazine and their malignancy was considered refractory to chemotherapy. The overall tumor response rate in these 54 patients was 22 percent, and the complete response rate was 9 percent.
The FDA reports that the most common side effects were nausea, vomiting, headache, fatigue, low blood counts and constipation. Severe vomiting may require antiemetic therapy before or during treatment.
COPYRIGHT 1999 American Academy of Family Physicians
COPYRIGHT 2000 Gale Group
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