General AML

FDA grants Trisenox® (arsenic trioxide) injection approval for the treatment of newly diagnosed low-risk APL

On 15th January 2018, the U.S. Food and Drug Administration (FDA) granted approval to Trisenox® (arsenic trioxide [ATO]) injection in combination with tretinoin for the treatment of adult patients with newly diagnosed low-risk Acute Promyelocytic Leukemia (APL) characterized by the presence of t(15;17) translocation or PML/RAR-alpha gene expression.

This approval for Trisenox® was based on the Priority Review granted by the FDA in September 2017, which was based on data from published scientific literature and a review of Teva’s (drug manufacturer) global safety database for ATO.

Trisenox® had been previously approved by the FDA and is indicated for induction of remission and consolidation in patients with APL with t(15;17) translocation or PML/RAR-alpha gene expression who are refractory to or relapsed after retinoid and anthracycline chemotherapy. This label expansion for Trisenox® by the FDA to include newly diagnosed APL “represents an important benefit” for patients according to the drug manufacturers.

References
  1. Teva News Release: Teva Announces U.S. FDA Approval of TRISENOX® (arsenic trioxide) Injection for First Line Treatment of Acute Promyelocytic Leukemia. http://www.tevapharm.com/news/teva_announces_u_s_fda_approval_of_trisenox_arsenic_trioxide_injection_for_first_line_treatment_of_acute_promyelocytic_leukemia_01_18.aspx [Accessed 2018 Jan 17].