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FDA Approves Arsenic Trioxide for Promyelocytic Leukemia

Silas Inman @silasinman
Published: Tuesday, Jan 16, 2018

The FDA has approved arsenic trioxide (Trisenox) in combination with the all-trans retinoic acid (ATRA) agent tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) with the t(15;17) translocation or PML-RARA gene expression.

Grade 3/4 thrombocytopenia and neutropenia lasting for >15 days was significantly more common in the chemotherapy group versus the arsenic trioxide arm. Grade 3/4 hepatic toxicity was more common with arsenic trioxide (63%) versus chemotherapy (6%). QTc interval prolongation was experienced by 16% of patients in the arsenic trioxide compared with none for chemotherapy.

In the induction phase, grade 3/4 thrombocytopenia for >15 days occurred for 88% of patients in the chemotherapy group versus 59% in the arsenic trioxide arm. Additionally, in the induction phase, 79% of patients in the chemotherapy group had grade 3/4 neutropenia lasting >15% compared with 46% in the arsenic trioxide group. In the consolidation period, few patients in the investigational arm experienced these events compared with similar rates for the chemotherapy arm.
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