TEMODAR SUMMARY
TEMODAR Capsules for oral administration contain temozolomide, an imidazotetrazine derivative.
TEMODAR (temozolomide) Capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma, ie, patients at first relapse who have experienced disease progression on a drug regimen containing a nitrosourea and procarbazine.
This indication is based on the response rate in the indicated population. No results are available from randomized controlled trials in recurrent anaplastic astrocytoma that demonstrate a clinical benefit resulting from treatment, such as improvement in disease-related symptoms, delayed disease progression, or improved survival.
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