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

On 15^th January 2018, the U.S. Food and Drug Administration (FDA) granted approval to 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 arsenic trioxide 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.

Arsenic trioxide 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 arsenic trioxide by the FDA to include newly diagnosed APL “represents an important benefit” for patients according to the drug manufacturers.