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From the Food and Drug Administration
November 1, 2000

New Treatment for Leukemia

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JAMA. 2000;284(17):2178. doi:10.1001/jama.284.17.2178-JFD00009-3-1

The FDA has approved arsenic trioxide (Trisenox injection, Cell Therapeutics Inc, Seattle, Wash) for induction of remission or consolidation in patients with acute promyelotic leukemia (APL) who are refractory to or have relapsed from all transretinoic acid– and anthracycline-based chemotherapy.

Arsenic trioxide converts immature cancerous white blood cells into normal white blood cells, but the mechanism is not fully understood. The drug's benefits were found to outweigh its risks in a study of 40 patients with relapsed or refractory APL who had been treated with an anthracycline and a retinoid regimen (ATRA). Patients received arsenic trioxide, 0.15 mg/kg per day intravenously for 1 to 2 hours, until the bone marrow was cleared of leukemic cells or a maximum of 60 days.

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