U.S. FDA Approves Trisenox® Injection for First Line Treatment of Acute Promyelocytic Leukemia

CancerConnect News: the U.S. Food and Drug Administration (FDA) has approved the use of Trisenox® (arsenic trioxide) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the (15;17) translocation or PML/RAR-alpha gene expression. The approval was based on a Priority Review by the FDA on data from published scientific literature and a review of the global safety database for arsenic trioxide.

Acute promyelocytic leukemia is a subset of acute myeloid leukemia (AML), a fast-growing cancer of the blood cells. APL is not common; it affects just approximately 1,500 individuals annually in the U.S.

APL is a cancer of the white blood cells (immune cells) that causes these cells to remain in an immature state, where they continue to replicate uncontrollably. The immature blood cells are not able to perform their intended function of fighting infection and also suppress the maturation of other blood cells.

Trisenox® is indicated for use in APL:

  • In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
  • For induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.

Reference:  https://www.reuters.com/article/brief-teva-announces-fda-approval-of-tri/brief-teva-announces-fda-approval-of-trisenox-to-treat-acute-promyelocytic-leukemia-idUSASB0C0WK

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