Trisenox Approved as First-Line Tx for Acute Promyelocytic Leukemia

Approval was based on a Priority Review by the FDA
Approval was based on a Priority Review by the FDA

Teva announced that the Food and Drug Administration (FDA) has approved Trisenox (arsenic trioxide) injection in combination with tretinoin as a first-line treatment for adults with newly diagnosed low-risk acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.

The expanded approval was based on data from scientific literature and a review of Teva's global safety database for arsenic trioxide. Trisenox, an arsenical agent, is now indicated:

  • 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

Trisenox is thought to cause morphological changes and DNA fragmentation characteristic of apoptosis in NB4 human promyelocytic leukemia cells in vitro. It also causes damage or degradation of the fusion protein promyelocytic leukemia (PML)-retinoic acid receptor (RAR) -alpha. 

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Trisenox is an injectable solution for intravenous (IV) administration supplied as 12mg/6mL of arsenic trioxide in single-dose vials.

For more information call (888) 483-8279 or visit Trisenox.com.